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CompletedNCT03467412Updated Dec 3, 2020Results posted

To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin

A Phase 2 interventional study of FOL-005 and Placebo in Androgenic Alopecia, sponsored by Follicum AB. Completed at 2 sites in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Follicum AB · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.

60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.

The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.

The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.

02

Conditions studied

  • Androgenic Alopecia

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03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male, aged 18-55 years
  • Androgenetic alopecia (AGA)) - Norwood/Hamilton grade 3V to 4/4a
  • Caucasian, skin type I - IV according to Fitzpatrick's classification

Exclusion criteria

Exclusion Criteria:

  • Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis or scalp atrophy
  • Any skin pathology (e.g. scar, nevus) or general condition (e.g. uncontrolled thyroid diseases) that in the investigator's opinion can interfere with the evaluation of the treatment areas or requires topical or systemic therapy
  • History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
  • Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
  • Diabetes mellitus
  • Coagulation deficiencies
  • Topical treatments for hair growth (minoxidil, anti-androgens or other agents known to affect hair growth) in the last 6 months
  • Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids in the last 2 months or other treatments that may affect hair growth
  • Platelet rich plasma (PRP) treatment on scalp during the last 12 months
  • Systemic therapy using retinoids, cyclosporine within the last 3 months
  • Systemic treatment with beta blockers or corticosteroids, scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months
  • Finasteride (e.g. Propecia®) or Dutasteride intake in the last 12 months, or any systemic hair therapy medication in the last 12 months
  • History of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria) or known skin cancer that in the opinion of the investigators might confound the results of the trial
  • History or clinical signs of keloids or hypertrophic scars
  • Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening
  • Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifylline, nitroglycerine) or anticoagulating drugs (e.g. heparins, cumarins, new oral anticoagulants, regular intake of acetylsalicylic acid)
  • Current or within 3 months prior to first dosing use of anti-inflammatory medication (ibuprofen, paracetamol is permitted), corticosteroids (nose drops, eye drops and/or inhalers are permitted) or immunosuppressive drugs taken for more than 2 consecutive weeks
  • Hair transplantation at any time
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    0.00625 μg FOL-005

    50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.

    Drug: FOL-005

  • Experimental
    0.025 μg FOL-005

    50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.

    Drug: FOL-005

  • Experimental
    0.050 μg FOL-005

    50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.

    Drug: FOL-005

  • Experimental
    0.100 μg FOL-005

    50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.

    Drug: FOL-005

  • Placebo comparator
    Placebo

    50 μl solution (placebo) injected intradermally three times per week for 12 weeks.

    Drug: Placebo

Interventions

  • DrugFOL-005

    intradermal injection

  • DrugPlacebo

    intradermal injection

05

What researchers measure

Primary outcomes

  1. Scalp Hair Density

    Change from baseline of total hair density (No. of hairs per cm"2") on the scalp

    Time frame: 12 weeks

Secondary outcomes

  1. Proportion of Anagen Hairs (%)

    Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)

    Time frame: From baseline to after 12 weeks treatment

  2. Change in Proportion of Telogen Hairs (%)

    Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of

    Time frame: From baseline to after 12 weeks treatment

  3. Anagen Hair Density

    Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.

    Time frame: From baseline to after 12 weeks treatment

  4. Change in Telogen Hair Density

    Change from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)

    Time frame: From baseline to after 12 weeks treatment

06

Results

Posted Dec 3, 2020

Participant flow

Participant flow — Overall Study
Milestone0.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Started2525252520
Completed2224202317
Not completed31523

Outcome measures

PrimaryScalp Hair Density

Change from baseline of total hair density (No. of hairs per cm"2") on the scalp

Time frame:
12 weeks
Reported as:
Mean · Change from baseline (No. of hairs/cm2)
Scalp Hair Density
Change from baseline (No. of hairs/cm2)0.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Scalp Hair Density1.46 ± 14.752.58 ± 15.36-4.10 ± 21.006.68 ± 22.245.60 ± 16.71
SecondaryProportion of Anagen Hairs (%)

Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)

Time frame:
From baseline to after 12 weeks treatment
Reported as:
Mean · percentage of anagen hairs
Proportion of Anagen Hairs (%)
percentage of anagen hairs0.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Proportion of Anagen Hairs (%)-0.03 ± 15.681.40 ± 11.43-0.73 ± 14.233.18 ± 15.16-3.08 ± 9.53
SecondaryChange in Proportion of Telogen Hairs (%)

Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of

Time frame:
From baseline to after 12 weeks treatment
Reported as:
Mean · percentage of telogen hairs
Change in Proportion of Telogen Hairs (%)
percentage of telogen hairs0.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Change in Proportion of Telogen Hairs (%)8.49 ± 31.36-0.05 ± 22.128.66 ± 34.712.21 ± 36.8214.60 ± 25.58
SecondaryAnagen Hair Density

Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.

Time frame:
From baseline to after 12 weeks treatment
Reported as:
Mean · number of hairs per cm2
Anagen Hair Density
number of hairs per cm20.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Anagen Hair Density-2.26 ± 28.893.65 ± 21.77-4.41 ± 24.855.79 ± 25.21-2.31 ± 19.70
SecondaryChange in Telogen Hair Density

Change from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)

Time frame:
From baseline to after 12 weeks treatment
Reported as:
Mean · number of hairs per cm2
Change in Telogen Hair Density
number of hairs per cm20.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005Placebo
Change in Telogen Hair Density3.72 ± 18.65-1.06 ± 16.330.31 ± 16.390.89 ± 22.157.91 ± 14.34

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
0.00625 μg FOL-0050/25 (0%)0/25 (0%)4/25 (16%)
0.025 μg FOL-0050/25 (0%)0/25 (0%)8/25 (32%)
0.050 μg FOL-0050/25 (0%)0/25 (0%)4/25 (16%)
0.100 μg FOL-0050/25 (0%)0/25 (0%)6/25 (24%)
Placebo0/20 (0%)0/20 (0%)5/20 (25%)
Systemic Adverse Events0/60 (0%)0/60 (0%)18/60 (30%)
Most frequent other events
Showing 10 of 12
Most frequent other events
Event0.00625 μg FOL-0050.025 μg FOL-0050.050 μg FOL-0050.100 μg FOL-005PlaceboSystemic Adverse Events
Skin exfoliationSkin and subcutaneous tissue disorders3/253/251/254/254/200/60
NasopharyngitisInfections and infestations0/250/250/250/250/2010/60
HeadacheNervous system disorders0/250/250/250/250/205/60
Influenza like illnessGeneral disorders0/250/250/250/250/205/60
Application site exfoliationGeneral disorders1/252/252/252/250/200/60
Rash pustularInfections and infestations0/252/250/251/251/200/60
Rash pustularInfections and infestations0/250/250/250/250/204/60
DiarrhoeaGastrointestinal disorders0/250/250/250/250/203/60
Application site eczemaGeneral disorders0/250/251/250/250/200/60
Application site pustulesInfections and infestations1/250/251/250/250/200/60

Baseline characteristics

In total 60 subjects were recruited. However, each subject received 2 treatments which leads up to the total number of subjects appears to be twice as many, i.e. 120. Baseline characteristics only reported for the total number of recruited subjects, i.e. 60.

Age, Categorical
Age, Categorical(Participants)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
<=18 years0
Between 18 and 65 years60
>=65 years0
Age, Continuous
Age, Continuous(years)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Mean39.4 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Female0
Male60
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Region of Enrollment
Region of Enrollment(participants)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Germany60
Weight
Weight(kg)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Mean84.91 ± 14.88
Height
Height(cm)Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
Mean180.6 ± 6.7
07

Study locations

2 sites
  • Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
    Berlin, 10117, Germany
  • Bioskin GmbH
    Hamburg, 20095, Germany
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 7, 2017

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

09

Registry details

Key details

Study ID
NCT03467412
Lead sponsor
Follicum AB
Collaborators
Bioskin GmbH
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Feb 27, 2018
Primary completion
Aug 22, 2018
Completion
Aug 22, 2018
Results posted
Dec 3, 2020
Last update
Dec 3, 2020

Study contacts

Ulrike Blume-Peytavi, Professor
principal investigator · Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

Oversight

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

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