E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068168 |
E.1.2 | Term | Androgenetic alopecia |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy male, aged 18-55 years - Androgentic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5, 5A, 5V (Hamilton, 1951)
|
|
E.4 | Principal 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)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The change in total (terminal+vellus) hair density (hair count (n per cm²)) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline and at end of treatment at day 112 |
|
E.5.2 | 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)
|
|
E.5.2.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |