Alopecia MedDRA version: 21.1 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: FOL-005 0.1% topical formulation
Product Code: FOL-005
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: Not available
Current Sponsor code: FOL-005
Other descriptive name:
Sponsors
Follicum AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy male, aged 18-55 years - Androgentic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5, 5A, 5V (Hamilton, 1951) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia - Diabetes mellitus - Presence of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria, folliculitis) or presence or history of known skin cancer that in the opinion of the Investigators might confound the results of the trial - Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders - Application of topical minoxidil preparation or any other topical over-the counter (OTC) or prescription medication for hair re-growth to scalp for 4 weeks or more during a 6 months period before enrollment - Use of or planned use of shampoo with expected medicinal effect on the scalp (e.g. but not limited to anti-dandruff containing ketoconazole, anti-psoriatic, anti-fungal or shampoo containing urea, caffeine, acetylsalicylic acid, etc.) during the course of trial - Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids or other treatments that may affect hair growth in the last 3 months as well as during the trial. - Systemic therapy using retinoids, cyclosporine, beta blockers or corticosteroids within the last 6 months as well as during the trial. - Finasterid (e.g. Propecia®) or Dutasteride intake in the last 12 months, or any systemic hair therapy medication in the last 12 months as well as during the trial. - Other systemic therapy which in the opinion of the Investigator might affect hair growth - Previously randomized in this trial (except for subjects withdrawn prematurely due to Covid-19 pandemic with at least 3 months washout period since last dose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of FOL-005 on scalp hair density in healthy male subjects with androgenetic alopecia when applied topically once daily for 16 weeks.;Secondary Objective: The secondary objective of this trial is to evaluate the efficacy of FOL-005 on scalp hair growth parameters at different assessment time points and to evaluate the safety and tolerability of 16 weeks of topical treatment with FOL-005 topical formulation in healthy male subjects with androgenetic alopecia.;Primary end point(s): The change in total (terminal+vellus) hair density (hair count (n per cm²)) ;Timepoint(s) of evaluation of this end point: At baseline and at end of treatment at day 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Comparisons of treatments on total (terminal+vellus) hair density at each post Baseline assessment time based on relative differences to Baseline - Comparisons of treatments on terminal hair density at each post Baseline assessment time based on relative differences to Baseline. - Comparisons of treatments on vellus hair density at each post Baseline assessment time based on relative differences to Baseline. - Comparison of the change from Baseline (Day 1) to each post Baseline assessment time in percentage of telogen hairs (number of telogen hairs /total number of hairs) for each IP separately. - Comparison of the change from Baseline (Day 1) to each post Baseline assessment time in percentage of anagen hairs (number of anagen hairs/total number of hairs) for each IP separately. - Local Tolerability - Premature trial termination due to adverse reactions - Safety parameters (adverse events, concomitant medication, laboratory parameter, vital signs) ;Timepoint(s) of evaluation of this end point: Efficacy end points will be assessed at baseline, at three months (day 84) and at end of treatment at day 112 Safety parameters will be assessed At baseline and bi-weekly until end of treatment at day 112 | — |
Countries
Germany
Contacts
Public ContactJan Alenfall
Follicum AB
Outcome results
None listed