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CompletedNCT03742518Updated Oct 1, 2026Results posted

A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

A Phase 2/3 interventional study of Topical SM04554 0.15% solution and Topical SM04554 0.25% solution in Androgenetic Alopecia, sponsored by Biosplice Therapeutics, Inc.. Completed at 14 sites in Turkey (Türkiye). Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Biosplice Therapeutics, Inc. · Phase 2/3, Interventional, and Treatment

Updated Oct 1, 2026Results postedPrimary outcomes revised+3 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
675
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.

Read the detailed description

This study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in Turkey of 2 different strengths of topical SM04554 solution applied QD to the scalp of male androgenetic alopecia (AGA) subjects - otherwise known as male pattern baldness.

Following a screening period of up to 2 weeks, subjects participated in the study for 54 weeks (48 weeks of treatment and 6 weeks of follow-up). Subjects were randomized into 1 of 3 groups in a 2:2:1 randomization scheme: SM04554 0.15% solution, SM04554 0.25% solution, and vehicle placebo.

Primary outcome of this study was change in absolute hair count as assessed by phototrichogram, a non-invasive and reproducible method to measure changes in hair.

02

Conditions studied

  • Androgenetic Alopecia

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Keywords

  • male pattern baldness
  • SM04554
  • AGA
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 675 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Biosplice Therapeutics, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Being a Turkish citizen
  • Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 3V or 4
  • Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
  • Willing and able to attend all study visits
  • Willing to maintain the same hair style and length as at the study start for the duration of the study
  • Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products (e.g., hair gel, mousse, styling spray) will be allowed on non-study visit days
  • Willing to use mild non-medicated shampoo and conditioner for the duration of the study
  • Able to read and understand Turkish
  • Ability to comprehend and willing to sign an informed consent form

Exclusion criteria

Exclusion Criteria:

  • Males who are sexually active, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use condom or whose partner is not using a highly effective method of birth control that includes double barrier, intrauterine device, or hormonal contraceptive combined with single barrier, or abstinence during the study treatment period until 90 days post last dose of study medication
  • Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
  • Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
  • History of surgical correction (e.g., hair transplantation, scalp reduction) of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of any products (e.g., finasteride, minoxidil, platelet rich plasma, biotin) or devices (e.g., laser light therapy) purported to promote scalp hair growth within 24 weeks prior to the start of the study
  • Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to the start of the study
  • Use of medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within 12 weeks prior to the start of the study
  • Current use of an occlusive wig, hair extensions, or hair weaves
  • History of hypersensitivity or allergies to any ingredient of the study medication
  • Participation in any other investigational drug or medical device trial, which includes or included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to the start of the study
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to the start of the study
  • Use of medicated shampoo or conditioner (medicated shampoo and conditioner refers to any prescription shampoo or conditioner as well as any over-the-counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth) within 30 days prior to the start of the study
  • Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
  • Subjects employed by Samumed, LLC or Samumed Turkey, or any of its affiliates or development partners (i.e., an employee, temporary contract worker, or designee) responsible for the conduct of the study
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
675 participants (actual)

Study arms

  • Experimental
    Topical SM04554 0.15% solution

    Topical SM04554 0.15% solution, once daily for up to 48 weeks

    Drug: Topical SM04554 0.15% solution

  • Experimental
    Topical SM04554 0.25% solution

    Topical SM04554 0.25% solution, once daily for up to 48 weeks

    Drug: Topical SM04554 0.25% solution

  • Placebo comparator
    Vehicle

    Topical vehicle solution, once daily for up to 48 weeks

    Drug: Topical vehicle solution

Interventions

  • DrugTopical SM04554 0.15% solution

    Study medication application will be performed by the individual subject at approximately the same time each day.

  • DrugTopical SM04554 0.25% solution

    Study medication application will be performed by the individual subject at approximately the same time each day.

  • DrugTopical vehicle solution

    Vehicle solution application will be performed by the individual subject at approximately the same time each day.

06

What researchers measure

Primary outcomes

  1. Absolute Non-vellus Hair Count in Target Area

    Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Week 48

Secondary outcomes

  1. Absolute Non-vellus Hair Count in Target Area

    Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Weeks 12, 24, and 36

  2. Absolute Vellus Hair Count in Target Area

    Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Weeks 12, 24, 36 and 48

  3. Absolute Total Hair Count in Target Area

    Total hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Weeks 12, 24, 36 and 48

  4. Change From Baseline in Non-vellus Hair Count in Target Area

    Change from baseline in non-vellus hair count in target area by PTG analysis. Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Baseline, and Weeks 12, 24, 36 and 48

  5. Change From Baseline in Vellus Hair Count in Target Area

    Change from baseline in vellus hair count in target area by PTG analysis. Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Baseline, and Weeks 12, 24, 36 and 48

  6. Change From Baseline in Total Hair Count in Target Area

    Change from baseline in total hair count in target area by PTG analysis. Vellus and non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Baseline, and Weeks 12, 24, 36 and 48

  7. Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area

    Change from baseline in average non-vellus hair shaft thickness in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

    Time frame: Baseline, and Weeks 12, 24, 36 and 48

  8. Change From Baseline in Average Non-vellus Hair Density in Target Area

    Change from baseline in average non-vellus hair density (cumulative non-vellus hair shaft thickness) in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. For this outcome, the cumulative non-vellus hair shaft thickness in the measurement area was summarized.

    Time frame: Baseline, and Weeks 12, 24, 36 and 48

  9. Improvement in Subject Assessment of Hair Growth

    Subjects will complete a questionnaire for hair growth while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). Improvement is defined as +1, +2, and +3: Much Better.

    Time frame: Weeks 6, 12, 18, 24, 30, 36, 42 and 48

  10. Change From Baseline in Subject Assessment of Hair Satisfaction

    Subjects will complete a questionnaire for hair satisfaction while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). The change from baseline is the difference between the baseline and follow-up response.

    Time frame: Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48

07

Results

Posted Oct 1, 2026

Participant flow

Participant flow — Overall Study
MilestonePlacebo0.15% SM045540.25% SM04554
Started134272269
Completed86174199
Not completed489870
Withdrew: Adverse event341
Withdrew: Death001
Withdrew: Lost to follow-up586
Withdrew: Physician decision011
Withdrew: Protocol violation81712
Withdrew: Withdrawal by subject316849
Withdrew: Military service assignment100

Outcome measures

PrimaryAbsolute Non-vellus Hair Count in Target Area

Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Week 48
Reported as:
Mean · Non-vellus hairs
Absolute Non-vellus Hair Count in Target Area
Non-vellus hairsPlacebo0.15% SM045540.25% SM04554
Baseline189.3 ± 84.0200.1 ± 85.6199.9 ± 90.7
Week 48193.8 ± 92.7208.0 ± 88.1207.2 ± 96.3
Statistical analysis
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.540 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0240 · 95% CI 0.9492 to 1.1047Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.745 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0136 · 95% CI 0.9346 to 1.0993Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
SecondaryAbsolute Non-vellus Hair Count in Target Area

Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Weeks 12, 24, and 36
Reported as:
Mean · Non-vellus hairs
Absolute Non-vellus Hair Count in Target Area
Non-vellus hairsPlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 12 data200.4 ± 84.0210.0 ± 86.7200.4 ± 88.0
Week 12201.9 ± 95.5212.3 ± 91.5211.7 ± 94.0
Baseline for subset of subjects with Week 24 data184.7 ± 80.6208.7 ± 84.7207.3 ± 89.5
Week 24187.8 ± 97.4213.7 ± 93.1204.2 ± 97.7
Baseline for subset of subjects with Week 36 data191.6 ± 85.1214.0 ± 85.8192.2 ± 87.9
Week 36190.8 ± 89.5214.8 ± 93.9198.5 ± 98.9
Statistical analysis
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.873 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0054 · 95% CI 0.9406 to 1.0748Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.271 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0420 · 95% CI 0.9684 to 1.1212Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.653 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0216 · 95% CI 0.9306 to 1.1215Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.618 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9746 · 95% CI 0.8809 to 1.0782Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.615 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0251 · 95% CI 0.9307 to 1.1291Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.554 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0315 · 95% CI 0.9307 to 1.1433Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
SecondaryAbsolute Vellus Hair Count in Target Area

Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Weeks 12, 24, 36 and 48
Reported as:
Mean · Vellus hairs
Absolute Vellus Hair Count in Target Area
Vellus hairsPlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 12 data135.8 ± 81.0134.1 ± 82.8145.4 ± 86.7
Week 12142.3 ± 83.5143.8 ± 92.2148.4 ± 85.2
Baseline for subset of subjects with Week 24 data140.7 ± 83.4130.6 ± 83.5135.0 ± 77.1
Week 24153.6 ± 91.4137.7 ± 86.8148.4 ± 84.3
Baseline for subset of subjects with Week 36 data133.0 ± 73.8131.2 ± 82.7143.8 ± 86.5
Week 36147.4 ± 78.6147.8 ± 96.2157.6 ± 97.5
Baseline for subset of subjects with Week 48 data144.7 ± 84.4136.9 ± 86.8146.0 ± 86.7
Week 48153.6 ± 86.9149.2 ± 95.3155.3 ± 95.2
Statistical analysis
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.783 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0143 · 95% CI 0.9168 to 1.1221Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.906 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9940 · 95% CI 0.8983 to 1.0998Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.282 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9383 · 95% CI 0.8355 to 1.0537Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.997 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9998 · 95% CI 0.8843 to 1.1303Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.910 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9919 · 95% CI 0.8618 to 1.1417Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.914 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9928 · 95% CI 0.8716 to 1.1309Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.993 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0004 · 95% CI 0.9062 to 1.1045Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.994 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9996 · 95% CI 0.9011 to 1.1089Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
SecondaryAbsolute Total Hair Count in Target Area

Total hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Weeks 12, 24, 36 and 48
Reported as:
Mean · Non-vellus and vellus hairs
Absolute Total Hair Count in Target Area
Non-vellus and vellus hairsPlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 12 data336.2 ± 83.9344.1 ± 89.9345.8 ± 89.6
Week 12344.2 ± 94.5356.1 ± 97.9360.1 ± 93.2
Baseline for subset of subjects with Week 24 data325.4 ± 80.6339.3 ± 88.6342.3 ± 88.0
Week 24341.4 ± 92.0351.5 ± 91.4352.6 ± 91.3
Baseline for subset of subjects with Week 36 data324.6 ± 82.4345.2 ± 93.2336.0 ± 91.2
Week 36338.3 ± 90.9362.5 ± 102.7356.1 ± 101.6
Baseline for subset of subjects with Week 48 data334.0 ± 83.1337.1 ± 91.8345.9 ± 89.2
Week 48347.4 ± 93.9357.2 ± 98.5362.6 ± 97.9
Statistical analysis
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.608 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0094 · 95% CI 0.9740 to 1.0461Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.321 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0164 · 95% CI 0.9843 to 1.0496Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.671 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9904 · 95% CI 0.9474 to 1.0354Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.490 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 0.9848 · 95% CI 0.9429 to 1.0286Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.656 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0129 · 95% CI 0.9574 to 1.0717Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.578 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0135 · 95% CI 0.9667 to 1.0625Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · Poisson regression · p = 0.493 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0148 · 95% CI 0.9731 to 1.0582Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · Poisson regression · p = 0.697 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Rate ratio: 1.0079 · 95% CI 0.9689 to 1.0484Rate ratio between SM04554 and Placebo hair count adjusted for baseline value.
SecondaryChange From Baseline in Non-vellus Hair Count in Target Area

Change from baseline in non-vellus hair count in target area by PTG analysis. Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Baseline, and Weeks 12, 24, 36 and 48
Reported as:
Mean · Non-vellus hair
Change From Baseline in Non-vellus Hair Count in Target Area
Non-vellus hairPlacebo0.15% SM045540.25% SM04554
Week 121.5 ± 57.22.3 ± 55.911.3 ± 61.9
Week 243.1 ± 55.65.0 ± 60.8-3.1 ± 69.4
Week 36-0.8 ± 57.20.8 ± 56.76.3 ± 60.4
Week 484.5 ± 49.67.9 ± 54.77.4 ± 61.9
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.763 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.00 · 95% CI -11.06 to 15.06Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.170 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 9.77 · 95% CI -4.20 to 23.74Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.601 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.51 · 95% CI -12.46 to 21.48Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.769 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -2.75 · 95% CI -21.19 to 15.69Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.613 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.62 · 95% CI -13.39 to 22.64Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.450 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 7.16 · 95% CI -11.51 to 25.83Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.494 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.88 · 95% CI -9.15 to 18.91Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.574 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.32 · 95% CI -10.78 to 19.42Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
SecondaryChange From Baseline in Vellus Hair Count in Target Area

Change from baseline in vellus hair count in target area by PTG analysis. Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Baseline, and Weeks 12, 24, 36 and 48
Reported as:
Mean · Vellus hair
Change From Baseline in Vellus Hair Count in Target Area
Vellus hairPlacebo0.15% SM045540.25% SM04554
Week 126.4 ± 59.49.8 ± 61.63.0 ± 69.5
Week 2412.9 ± 56.27.2 ± 61.213.4 ± 73.2
Week 3614.4 ± 62.716.6 ± 69.013.8 ± 65.6
Week 488.8 ± 54.912.2 ± 59.59.3 ± 66.5
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.671 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 3.01 · 95% CI -10.95 to 16.98Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.950 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.46 · 95% CI -14.93 to 14.01Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.358 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -7.72 · 95% CI -24.25 to 8.80Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.909 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -1.08 · 95% CI -19.61 to 17.45Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.868 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.76 · 95% CI -19.13 to 22.66Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.894 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.36 · 95% CI -18.75 to 21.47Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.775 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.23 · 95% CI -13.09 to 17.54Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.930 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.72 · 95% CI -15.43 to 16.86Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
SecondaryChange From Baseline in Total Hair Count in Target Area

Change from baseline in total hair count in target area by PTG analysis. Vellus and non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Baseline, and Weeks 12, 24, 36 and 48
Reported as:
Mean · Vellus and non-vellus hair
Change From Baseline in Total Hair Count in Target Area
Vellus and non-vellus hairPlacebo0.15% SM045540.25% SM04554
Week 128.0 ± 44.912.0 ± 53.214.3 ± 44.3
Week 2416.0 ± 50.512.2 ± 52.910.4 ± 51.8
Week 3613.6 ± 49.417.3 ± 63.220.1 ± 47.6
Week 4813.4 ± 47.420.1 ± 58.116.7 ± 52.4
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.453 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.56 · 95% CI -7.38 to 16.49Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.193 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 6.94 · 95% CI -3.53 to 17.41Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.766 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -2.23 · 95% CI -16.97 to 12.52Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.603 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -3.84 · 95% CI -18.34 to 10.67Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.534 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 5.94 · 95% CI -12.90 to 24.79Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.387 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 6.76 · 95% CI -8.63 to 22.16Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.345 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 7.04 · 95% CI -7.60 to 21.68Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.559 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 3.98 · 95% CI -9.43 to 17.40Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
SecondaryChange From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area

Change from baseline in average non-vellus hair shaft thickness in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.

Time frame:
Baseline, and Weeks 12, 24, 36 and 48
Reported as:
Mean · mm
Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area
mmPlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 12 data0.0593 ± 0.00730.0599 ± 0.00770.0588 ± 0.0073
Week 12-0.0003 ± 0.0055-0.0005 ± 0.0052-0.0002 ± 0.0049
Baseline for subset of subjects with Week 24 data0.0587 ± 0.00760.0604 ± 0.00810.0597 ± 0.0069
Week 24-0.0011 ± 0.0047-0.0011 ± 0.0050-0.0016 ± 0.0056
Baseline for subset of subjects with Week 36 data0.0590 ± 0.00760.0603 ± 0.00770.0588 ± 0.0069
Week 36-0.0017 ± 0.0054-0.0019 ± 0.0043-0.0015 ± 0.0047
Baseline for subset of subjects with Week 48 data0.0580 ± 0.00620.0592 ± 0.00760.0590 ± 0.0073
Week 48-0.0005 ± 0.0045-0.0004 ± 0.0046-0.0003 ± 0.0047
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.975 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0000 · 95% CI -0.0012 to 0.0012Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.994 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0000 · 95% CI -0.0011 to 0.0011Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.558 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0004 · 95% CI -0.0009 to 0.0017Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.777 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.0002 · 95% CI -0.0016 to 0.0012Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.733 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0002 · 95% CI -0.0011 to 0.0015Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.829 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0002 · 95% CI -0.0012 to 0.0016Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.565 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0004 · 95% CI -0.0008 to 0.0015Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.446 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.0004 · 95% CI -0.0007 to 0.0016Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
SecondaryChange From Baseline in Average Non-vellus Hair Density in Target Area

Change from baseline in average non-vellus hair density (cumulative non-vellus hair shaft thickness) in target area by PTG analysis. Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place. For this outcome, the cumulative non-vellus hair shaft thickness in the measurement area was summarized.

Time frame:
Baseline, and Weeks 12, 24, 36 and 48
Reported as:
Mean · mm
Change From Baseline in Average Non-vellus Hair Density in Target Area
mmPlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 12 data12.1619 ± 5.864312.9444 ± 6.270112.0919 ± 6.1197
Week 120.1459 ± 4.17010.0271 ± 3.97930.6008 ± 4.0966
Baseline for subset of subjects with Week 24 data11.1398 ± 5.748912.9622 ± 6.227712.6519 ± 6.1587
Week 240.0926 ± 3.70380.0607 ± 4.1155-0.4935 ± 4.6685
Baseline for subset of subjects with Week 36 data11.5866 ± 5.913113.2184 ± 6.168711.5524 ± 5.8486
Week 36-0.3423 ± 3.8668-0.3645 ± 3.75850.1327 ± 4.0204
Baseline for subset of subjects with Week 48 data11.2055 ± 5.573112.1688 ± 5.911112.1332 ± 6.3690
Week 480.1954 ± 3.31800.4132 ± 3.49950.4061 ± 4.1782
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.988 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.0069 · 95% CI -0.9410 to 0.9271Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.358 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.4438 · 95% CI -0.5047 to 1.3923Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.690 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.2292 · 95% CI -0.9007 to 1.3591Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.606 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.3208 · 95% CI -1.5463 to 0.9047Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.679 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.2489 · 95% CI -0.9349 to 1.4327Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.455 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.4700 · 95% CI -0.7684 to 1.7083Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.482 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.3279 · 95% CI -0.5884 to 1.2442Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.516 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.3366 · 95% CI -0.6823 to 1.3555Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
SecondaryImprovement in Subject Assessment of Hair Growth

Subjects will complete a questionnaire for hair growth while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). Improvement is defined as +1, +2, and +3: Much Better.

Time frame:
Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Reported as:
Count of participants · Participants
Improvement in Subject Assessment of Hair Growth
ParticipantsPlacebo0.15% SM045540.25% SM04554
Week 65295101
Week 1250118125
Week 184498122
Week 24407596
Week 30328091
Week 36276276
Week 42205361
Week 484282102
Statistical analysis
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.313 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 0.80 · 95% CI 0.51 to 1.24SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.551 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 0.87 · 95% CI 0.56 to 1.36SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.350 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.24 · 95% CI 0.79 to 1.95SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.181 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.36 · 95% CI 0.87 to 2.14SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.667 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.11 · 95% CI 0.68 to 1.82SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.076 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.55 · 95% CI 0.96 to 2.53SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.880 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 0.96 · 95% CI 0.56 to 1.63SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.216 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.39 · 95% CI 0.82 to 2.36SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.252 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.39 · 95% CI 0.79 to 2.46SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.064 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.71 · 95% CI 0.97 to 3.00SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.686 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.13 · 95% CI 0.62 to 2.07SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.109 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.63 · 95% CI 0.90 to 2.98SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.411 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.32 · 95% CI 0.68 to 2.59SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.138 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.66 · 95% CI 0.85 to 3.24SM04554 vs placebo in improvement response.
  • Placebo vs 0.15% SM04554 · Regression, Logistic · p = 0.631 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 0.88 · 95% CI 0.52 to 1.48SM04554 vs placebo in improvement response.
  • Placebo vs 0.25% SM04554 · Regression, Logistic · p = 0.732 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Odds ratio (or): 1.09 · 95% CI 0.65 to 1.83SM04554 vs placebo in improvement response.
SecondaryChange From Baseline in Subject Assessment of Hair Satisfaction

Subjects will complete a questionnaire for hair satisfaction while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). The change from baseline is the difference between the baseline and follow-up response.

Time frame:
Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Reported as:
Mean · units on a scale
Change From Baseline in Subject Assessment of Hair Satisfaction
units on a scalePlacebo0.15% SM045540.25% SM04554
Baseline for subset of subjects with Week 6 data-0.6 ± 1.8-0.8 ± 1.9-0.8 ± 1.8
Week 60.9 ± 1.70.9 ± 1.80.8 ± 1.8
Baseline for subset of subjects with Week 12 data-0.3 ± 1.8-0.4 ± 1.8-0.2 ± 1.7
Week 121.2 ± 2.11.3 ± 1.91.5 ± 1.9
Baseline for subset of subjects with Week 18 data-0.3 ± 1.7-0.2 ± 1.7-0.1 ± 1.7
Week 181.2 ± 1.91.5 ± 1.91.6 ± 2.0
Baseline for subset of subjects with Week 24 data-0.1 ± 1.7-0.2 ± 1.7-0.2 ± 1.7
Week 241.3 ± 1.91.6 ± 2.01.4 ± 1.9
Baseline for subset of subjects with Week 30 data-0.3 ± 1.6-0.2 ± 1.70.0 ± 1.6
Week 301.2 ± 1.91.5 ± 2.11.6 ± 1.9
Baseline for subset of subjects with Week 36 data-0.2 ± 1.6-0.1 ± 1.50.2 ± 1.4
Week 361.4 ± 1.81.6 ± 1.81.8 ± 1.9
Baseline for subset of subjects with Week 42 data-0.1 ± 1.6-0.2 ± 1.70.2 ± 1.5
Week 421.3 ± 1.91.4 ± 2.01.8 ± 1.9
Baseline for subset of subjects with Week 48 data0.1 ± 1.80.1 ± 1.70.3 ± 1.6
Week 481.8 ± 2.11.8 ± 2.11.9 ± 2.0
Statistical analysis
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.558 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.10 · 95% CI -0.46 to 0.25Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.368 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.16 · 95% CI -0.51 to 0.19Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.984 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.00 · 95% CI -0.37 to 0.38Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.395 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.16 · 95% CI -0.21 to 0.54Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.434 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.16 · 95% CI -0.24 to 0.55Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.247 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.23 · 95% CI -0.16 to 0.62Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.907 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.03 · 95% CI -0.46 to 0.41Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.794 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.06 · 95% CI -0.47 to 0.36Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.525 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.15 · 95% CI -0.31 to 0.61Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.118 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.35 · 95% CI -0.09 to 0.78Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.738 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.07 · 95% CI -0.36 to 0.51Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.139 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.33 · 95% CI -0.11 to 0.76Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.943 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.02 · 95% CI -0.51 to 0.54Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.097 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.41 · 95% CI -0.07 to 0.89Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.15% SM04554 · ANCOVA · p = 0.982 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.01 · 95% CI -0.45 to 0.44Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.
  • Placebo vs 0.25% SM04554 · ANCOVA · p = 0.389 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.19 · 95% CI -0.24 to 0.61Least squares estimate of difference (SM04554 - Placebo) is based on a change from baseline ANCOVA model, adjusted for baseline value.

Adverse events

Collected over AEs will be assessed at each study visit from the time of the first study medication application through to Week 54 (EOS) or Early Termination.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/134 (0%)2/134 (1.5%)16/134 (11.9%)
0.15% SM045540/272 (0%)1/272 (0.4%)36/272 (13.2%)
0.25% SM045542/269 (0.7%)3/269 (1.1%)19/269 (7.1%)
Most frequent serious events
Most frequent serious events
EventPlacebo0.15% SM045540.25% SM04554
Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1340/2720/269
Vocal cord neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1340/2720/269
COVID-19Infections and infestations0/1341/2721/269
Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1340/2721/269
COVID-19 pneumoniaInfections and infestations0/1340/2721/269
Most frequent other events
Showing 10 of 45
Most frequent other events
EventPlacebo0.15% SM045540.25% SM04554
Application site pruritusGeneral disorders and administration site conditions1/13410/2726/269
NasopharyngitisInfections and infestations3/1341/2721/269
HeadacheNervous system disorders2/1346/2720/269
COVID-19Infections and infestations0/1343/2725/269
Blood lactate dehydrogenase increasedInvestigations2/1340/2720/269
Back painMusculoskeletal and connective tissue disorders2/1340/2720/269
Application site painGeneral disorders and administration site conditions0/1344/2720/269
Aspartate aminotransferase increasedInvestigations0/1343/2720/269
PruritusSkin and subcutaneous tissue disorders0/1343/2720/269
TinnitusEar and labyrinth disorders1/1340/2720/269

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo0.15% SM045540.25% SM04554Total
Mean34.0 ± 6.833.1 ± 6.833.9 ± 6.733.6 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)Placebo0.15% SM045540.25% SM04554Total
Female0000
Male134272269675
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo0.15% SM045540.25% SM04554Total
Hispanic or Latino1001
Not Hispanic or Latino133272269674
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo0.15% SM045540.25% SM04554Total
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White134272269675
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Placebo0.15% SM045540.25% SM04554Total
Turkey134272269675
Weight [kg]
Weight [kg](kg)Placebo0.15% SM045540.25% SM04554Total
Mean81.3 ± 11.3281.64 ± 11.6282.18 ± 13.0381.79 ± 12.13
Height [cm]
Height [cm](cm)Placebo0.15% SM045540.25% SM04554Total
Mean175.0 ± 6.1176.0 ± 6.8175.5 ± 6.7175.6 ± 6.6
Body Mass Index [kg/m²]
Body Mass Index [kg/m²](kg/m²)Placebo0.15% SM045540.25% SM04554Total
Mean26.54 ± 3.4926.32 ± 3.2326.65 ± 3.6426.49 ± 3.45

1 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • Research Site
    Ankara, 06100, Turkey (Türkiye)
  • Research Site
    Ankara, 06110, Turkey (Türkiye)
  • Research Site
    Ankara, 06680, Turkey (Türkiye)
  • Research Site
    Bursa, 16059, Turkey (Türkiye)
  • Research Site
    Denizli, 20070, Turkey (Türkiye)
  • Research Site
    Istanbul, 34098, Turkey (Türkiye)
  • Research Site
    Istanbul, 34668, Turkey (Türkiye)
  • Research Site
    Izmir, 35180, Turkey (Türkiye)
  • Research Site
    Kayseri, 38039, Turkey (Türkiye)
  • Research Site
    Kocaeli, 41380, Turkey (Türkiye)
  • Research Site
    Mersin, 33343, Turkey (Türkiye)
  • Research Site
    Samsun, 55139, Turkey (Türkiye)
  • Research Site 1
    Trabzon, 61080, Turkey (Türkiye)
  • Research Site 2
    Trabzon, 61080, Turkey (Türkiye)
09

References and documents

Study documents

  • Study protocol · Jun 10, 2019
  • Statistical analysis plan · Mar 9, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 1, 2026
Sites
1 site added, 1 site removed
Show site
  • Research Site · Izmir, Turkey (Türkiye)
Show 1 removed
  • Research Site · İzmir, Turkey
Oct 1, 2026
Also revised
primary outcomes and interventions
Show all 1 update
  1. Oct 1, 2026
    Results posted
    1 site added, 1 site removed
    Show site
    • Research Site · Izmir, Turkey (Türkiye)
    Show 1 removed
    • Research Site · İzmir, Turkey
    Primary outcomes Revised (2 changes)
    Interventions Arms or interventions changed
    + 6 other changes: verification date, registry dates, description, secondary outcomes, index terms and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03742518
Lead sponsor
Biosplice Therapeutics, Inc.
Responsible party
Sponsor
First posted
Nov 15, 2018
Start date
Nov 1, 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Results posted
Oct 1, 2026
Last update
Oct 1, 2026

Study contacts

Yusuf Yazici, M.D.
study director · Biosplice Therapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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