CClinicalTrials.gg
Sign In
CompletedNCT02503137Updated Oct 1, 2026Results posted

A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

A Phase 2 interventional study of Topical SM04554 solution and Topical SM04554 solution in Androgenetic Alopecia, sponsored by Biosplice Therapeutics, Inc.. Completed at 5 sites in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

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

Updated Oct 1, 2026Results postedPrimary outcomes revised+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of SM04554.

02

Conditions studied

  • Androgenetic Alopecia

Browse trials for

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 49 is close to 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 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V, or 6
  • In good general health, as determined by the Investigator
  • Willing and able to attend all study visits
  • Willing to undergo two punch biopsies of the scalp
  • 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 to not use permanent or semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products will be allowed on non-study visit days (e.g., hair gel, mousse, styling spray)
  • Willing to use sponsor-supplied shampoo and conditioner in place of regular shampoo and conditioner, for the duration of the study; use of sponsor-supplied conditioner is optional for subjects who do not use conditioner

Exclusion criteria

Exclusion Criteria:

  • 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
  • Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using a highly effective method of birth control and are not willing to use a highly effective method of birth control during the study treatment period until 90 days post last dose of study medication
  • Current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
  • History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell carcinoma) located anywhere on the body
  • History of surgical correction of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of blood thinners (e.g., Coumadin, Plavix, Lovenox, and aspirin >81mg); low dose aspirin (e.g., ≤81 mg) is allowable
  • Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 24 weeks prior to study start
  • Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to study start
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
  • Use of medicated shampoo or conditioner (medicated shampoo and conditioner refer 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 study start
  • History of hair transplants
  • Current use of an occlusive wig, hair extensions, or hair weaves
  • Participation in any other investigational drug or medical device trial which 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 study start
  • Poor peripheral venous access
  • Subjects unwilling to refrain from sperm donation during the study treatment period until 90 days post last dose of study medication
  • Subjects with pregnant partners at study start
  • 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 any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Topical SM04554 0.15% solution

    Topical SM04554 0.15% solution, once daily for approximately 90 days

    Drug: Topical SM04554 solution

  • Experimental
    Topical SM04554 0.25% solution

    Topical SM04554 0.25% solution, once daily for approximately 90 days

    Drug: Topical SM04554 solution

  • Placebo comparator
    Vehicle

    Topical vehicle solution, once daily for approximately 90 days

    Drug: Topical vehicle solution

Interventions

  • DrugTopical SM04554 solution

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

  • DrugTopical SM04554 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. Change From Baseline/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  2. Change From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  3. Change From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  4. Change From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  5. Change From Baseline/Day 91 in Number of Indeterminate Hair Follicles

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  6. Change From Baseline/Day 91 in Number of Vellus Hair Follicles

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

Secondary outcomes

  1. Terminal and Miniaturized Hair Follicle Density/mm²

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  2. Ratio of Terminal to Miniaturized Hair Follicles

    Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  3. Beta-catenin in Epidermis and Infundibulum

    Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  4. Ki-67 in Epidermis and Infundibulum

    Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

  5. Ki-67 in Hair Bulb

    Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

    Time frame: Day 91 and Day 135

07

Results

Posted Oct 1, 2026

Participant flow

Participant flow — Overall Study
MilestoneSM04554 0.15%SM04554 0.25%Vehicle
Started161419
Completed121117
Not completed432
Withdrew: Lost to follow-up100
Withdrew: Withdrawal by subject122
Withdrew: Protocol violation110
Withdrew: Prohibited medication100

Outcome measures

PrimaryChange From Baseline/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Terminal Hair Follicles (Terminal Anagen + Terminal Catagen and Telogen Follicles)
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-1.6 ± 3.8-0.3 ± 7.2-1.7 ± 4.1
Day 135 - Change from Baseline-2.1 ± 8.0-2.7 ± 6.0-3.5 ± 3.9
Day 135 - Change from Day 91-1.4 ± 5.0-0.1 ± 4.3-1.9 ± 4.1
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.9740 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.05Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1277 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.75Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.2379 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.06Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.5776 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.93Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.5369 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.13Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3955 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.49Least squares estimate of difference (SM04554 - Vehicle).
PrimaryChange From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Terminal Anagen Hair Follicles
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-1.1 ± 3.31.3 ± 5.4-1.1 ± 3.7
Day 135 - Change from Baseline-2.4 ± 4.1-0.9 ± 2.7-1.9 ± 3.5
Day 135 - Change from Day 91-1.5 ± 2.3-0.6 ± 3.7-0.9 ± 3.1
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.9560 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.07Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.4476 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.78Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.6285 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.59Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1882 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.78Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.6965 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.41Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.9177 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.13Least squares estimate of difference (SM04554 - Vehicle).
PrimaryChange From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Terminal Catagen and Telogen Hair Follicles
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-0.5 ± 2.8-1.6 ± 3.4-0.6 ± 2.3
Day 135 - Change from Baseline0.3 ± 5.7-1.9 ± 4.6-1.6 ± 1.9
Day 135 - Change from Day 910.1 ± 5.20.4 ± 1.6-1.0 ± 2.0
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.7323 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.26Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1689 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.45Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1711 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.53Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.3437 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.73Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1108 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.83Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2400 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.36Least squares estimate of difference (SM04554 - Vehicle).
PrimaryChange From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Miniaturized Hair Follicles (Indeterminate + Vellus Follicles)
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-1.8 ± 18.30.3 ± 19.0-5.0 ± 11.5
Day 135 - Change from Baseline4.1 ± 13.11.4 ± 5.3-2.8 ± 7.7
Day 135 - Change from Day 918.0 ± 18.7-3.9 ± 19.24.4 ± 14.0
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.5815 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.95Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.0665 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 7.92Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1663 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 8.91Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1243 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 8.73Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1548 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 6.68Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3205 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 7.74Least squares estimate of difference (SM04554 - Vehicle).
PrimaryChange From Baseline/Day 91 in Number of Indeterminate Hair Follicles

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Indeterminate Hair Follicles
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-0.4 ± 5.13.1 ± 5.50.1 ± 5.3
Day 135 - Change from Baseline1.4 ± 4.31.1 ± 4.30.2 ± 3.6
Day 135 - Change from Day 911.5 ± 5.1-1.9 ± 4.1-1.3 ± 5.3
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.9085 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.21Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.2640 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 1.97Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.0944 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 3.21Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.0292 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.22Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2540 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.17Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3073 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.15Least squares estimate of difference (SM04554 - Vehicle).
PrimaryChange From Baseline/Day 91 in Number of Vellus Hair Follicles

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Hair Count
Change From Baseline/Day 91 in Number of Vellus Hair Follicles
Hair CountSM04554 0.15%SM04554 0.25%Vehicle
Day 91 (Primary) - Change from Baseline-1.5 ± 16.3-2.8 ± 16.0-5.1 ± 11.2
Day 135 - Change from Baseline2.8 ± 12.70.3 ± 5.6-3.0 ± 7.8
Day 135 - Change from Day 916.5 ± 14.4-2.0 ± 15.45.7 ± 11.0
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.5076 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 3.12Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1153 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 6.41Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.3527 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.97Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3271 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 4.81Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2057 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 5.56Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.6078 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 3.30Least squares estimate of difference (SM04554 - Vehicle).
SecondaryTerminal and Miniaturized Hair Follicle Density/mm²

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · number of follicles per square mm
Terminal and Miniaturized Hair Follicle Density/mm²
number of follicles per square mmSM04554 0.15%SM04554 0.25%Vehicle
Day 91 - Change from Baseline-0.3 ± 1.6-0.0 ± 1.2-0.5 ± 1.0
Day 135 - Change from Baseline0.2 ± 1.2-0.1 ± 0.7-0.5 ± 0.6
Day 135 - Change from Day 910.5 ± 1.2-0.3 ± 1.30.2 ± 1.1
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.5665 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.23Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.0205 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.84Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1142 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.79Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.0666 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.78Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.0563 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.74Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3899 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.52Least squares estimate of difference (SM04554 - Vehicle).
SecondaryRatio of Terminal to Miniaturized Hair Follicles

Scalp biopsies were used to analyze the outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Change from baseline is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · ratio
Ratio of Terminal to Miniaturized Hair Follicles
ratioSM04554 0.15%SM04554 0.25%Vehicle
Day 91 - Change from Baseline0.40 ± 1.100.04 ± 0.33-0.17 ± 0.43
Day 135 - Change from Baseline-0.02 ± 0.28-0.08 ± 0.19-0.06 ± 0.62
Day 135 - Change from Day 91-0.80 ± 1.24-0.05 ± 0.260.13 ± 0.70
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.0391 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.55Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.9792 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.01Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1851 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.36Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.4966 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.18Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.7530 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.07Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2614 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.30Least squares estimate of difference (SM04554 - Vehicle).
SecondaryBeta-catenin in Epidermis and Infundibulum

Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · percentage of nuclei stained positive
Beta-catenin in Epidermis and Infundibulum
percentage of nuclei stained positiveSM04554 0.15%SM04554 0.25%Vehicle
Day 91 - Change from Baseline1.7 ± 2.3-0.9 ± 2.8-0.3 ± 2.1
Day 135 - Change from Baseline1.5 ± 2.5-1.0 ± 3.11.2 ± 2.9
Day 135 - Change from Day 91-0.3 ± 0.50.4 ± 0.51.1 ± 1.6
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.8454 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.12Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.2715 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.93Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.1830 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.91Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.5201 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.34Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1624 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -1.25Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.1442 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -0.89Least squares estimate of difference (SM04554 - Vehicle).
SecondaryKi-67 in Epidermis and Infundibulum

Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Percent of cells that stain positive
Ki-67 in Epidermis and Infundibulum
Percent of cells that stain positiveSM04554 0.15%SM04554 0.25%Vehicle
Day 91 - Change from Baseline13.2 ± 9.013.1 ± 19.211.1 ± 16.1
Day 135 - Change from Baseline5.8 ± 9.26.3 ± 12.08.8 ± 16.4
Day 135 - Change from Day 91-7.6 ± 10.1-8.5 ± 17.30.0 ± 15.4
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 1.0000 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 0.00Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.4279 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -5.08Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.4041 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -5.66Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.7194 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 2.52Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2612 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -7.00Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.5729 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): -4.14Least squares estimate of difference (SM04554 - Vehicle).
SecondaryKi-67 in Hair Bulb

Immunohistochemistry of scalp biopsies were used to analyze the nuclear expression outcome measure at baseline (prior to initiating therapy) and at each subsequent timepoint. Percentage of positively-stained nuclei were reported at each timepoint. Change from baseline in percentage of positively-stained nuclei is the difference between follow-up and baseline. Change from Day 91 is the difference between Day 135 and Day 91.

Time frame:
Day 91 and Day 135
Reported as:
Mean · Percent of cells that stain positive
Ki-67 in Hair Bulb
Percent of cells that stain positiveSM04554 0.15%SM04554 0.25%Vehicle
Day 91 - Change from Baseline4.9 ± 21.73.2 ± 19.1-11.7 ± 21.6
Day 135 - Change from Baseline-7.5 ± 26.910.8 ± 19.2-15.6 ± 29.2
Day 135 - Change from Day 91-1.9 ± 13.3-3.0 ± 9.0-6.6 ± 26.8
Statistical analysis
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.0886 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 13.84Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.4579 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 9.03Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.15% vs Vehicle · ANCOVA · p = 0.3018 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 9.39Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2479 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 10.13Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.2608 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 16.24Least squares estimate of difference (SM04554 - Vehicle).
  • SM04554 0.25% vs Vehicle · ANCOVA · p = 0.3412 (Unadjusted, Bonferroni correction alpha is 0.025 for the two treatment comparisons.) · Mean difference (final values): 9.74Least squares estimate of difference (SM04554 - Vehicle).

Adverse events

Collected over Treatment-emergent AEs reporting start with the subject's first exposure to study medication at Day 1 through Day 135 (End of Study) or early termination.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SM04554 0.15%0/16 (0%)0/16 (0%)9/16 (56.3%)
SM04554 0.25%0/14 (0%)0/14 (0%)9/14 (64.3%)
Vehicle0/19 (0%)0/19 (0%)11/19 (57.9%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventSM04554 0.15%SM04554 0.25%Vehicle
Application site pruritusGeneral disorders and administration site conditions2/161/142/19
ContusionInjury, poisoning and procedural complications2/160/140/19
Skin exfoliationSkin and subcutaneous tissue disorders2/160/141/19
Upper respiratory tract infectionInfections and infestations1/161/142/19
Pain of skinSkin and subcutaneous tissue disorders0/160/142/19
ConstipationGastrointestinal disorders0/161/140/19
DiarrhoeaGastrointestinal disorders0/161/141/19
Application site paraesthesiaGeneral disorders and administration site conditions0/161/141/19
NasopharyngitisInfections and infestations1/161/140/19
PneumoniaInfections and infestations0/161/140/19

Baseline characteristics

Age, Continuous
Age, Continuous(years)SM04554 0.15%SM04554 0.25%VehicleTotal
Mean49.5 ± 11.848.2 ± 11.250.5 ± 9.349.5 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)SM04554 0.15%SM04554 0.25%VehicleTotal
Female0000
Male16141949
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SM04554 0.15%SM04554 0.25%VehicleTotal
Hispanic or Latino1001
Not Hispanic or Latino15141948
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SM04554 0.15%SM04554 0.25%VehicleTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American44715
White12101234
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)SM04554 0.15%SM04554 0.25%VehicleTotal
United States16141949
Weight [kg]
Weight [kg](kg)SM04554 0.15%SM04554 0.25%VehicleTotal
Mean105.2 ± 30.093.2 ± 23.889.8 ± 16.295.8 ± 24.0
Height [cm]
Height [cm](cm)SM04554 0.15%SM04554 0.25%VehicleTotal
Mean178.0 ± 5.2177.3 ± 6.3176.9 ± 6.9177.4 ± 6.1
Body Mass Index [kg/m²]
Body Mass Index [kg/m²](kg/m²)SM04554 0.15%SM04554 0.25%VehicleTotal
Mean33.1 ± 8.929.5 ± 6.628.7 ± 5.130.4 ± 7.1

1 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • Research Site
    Clinton Township, Michigan, United States
  • Research Site
    Cleveland, Ohio, United States
  • Research Site
    College Station, Texas, United States
  • Research Site
    Houston, Texas, United States
  • Research Site
    Lynchburg, Virginia, United States
09

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 1, 2026
Also revised
primary outcomes and interventions
Show all 1 update
  1. Oct 1, 2026
    Results posted
    Primary outcomes Revised (12 changes)
    Interventions Arms or interventions changed
    + 3 other changes: verification date, secondary outcomes and index terms

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 ↗

10

Registry details

Key details

Study ID
NCT02503137
Lead sponsor
Biosplice Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jul 20, 2015
Start date
Aug 2015
Primary completion
Apr 2016
Completion
Apr 2016
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 ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alopecia→

Other studies from this sponsor

Biosplice Therapeutics, Inc.

Start the discussion