Alopecia. MedDRA version: 20.0 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: FOL-005
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
Current Sponsor code: FOL-005
Other
Sponsors
Follicum AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male, aged 18-55 years 2. Androgenetic alopecia (AGA)) – Norwood/Hamilton grade 3V to 4/4a 3. Caucasian, skin type I – IV according to Fitzpatrick’s classification 4. Willing to have treatment areas shaved for TrichoScan® measurement marked with small semi-permanent dot tattoos 5. Willing to maintain the same hygiene products and skin cleansing habits during the trial period. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test sites risking interfering with investigational evaluations 2. Any dermatological disorders of the scalp or skin pathology which might interfere with the application of IMP or examination method 3. History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia 4. 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 5. Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders 6. Diabetes mellitus 7. Coagulation deficiencies 8. Known or suspected allergy or sensitization to cosmetic hair dyes or hypersensitivity to ingredients of the IMP or tattoo ink. 9. Any topical or systemic treatments with agents, known or suspected to affect hair growth 10. Use of or planned use of any shampoo with expected medicinal effect on the scalp (e.g. but not limited to antifungal or anti-dandruff shampoo, shampoo containing urea, caffeine or acetylsalicylic acid, etc.) during the course of the trial 11. Elevated values for vital signs: • blood pressure: systolic above 160 mmHg, diastolic above 95 mmHg • heart rate: above 100 beats/min. 12. Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants, regular intake of acetylsalicylic acid) 13. 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 14. Current or within the last 6 months history of severe dietary or weight changes 15. Hair transplantation at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FOL-005 on scalp hair density in healthy male subjects when applied intradermally three times a week for 12 weeks.; Secondary Objective: To evaluate the efficacy of FOL-005 on scalp hair density in healthy male subjects when applied intradermally three times weekly for 8 weeks and to evaluate the safety and tolerability of 12 weeks of treatment with FOL-005 in healthy male subjects. ; Primary end point(s): Change from baseline of total hair density (No. of hairs per cm2) on the scalp after 12 weeks of treatment. ; Timepoint(s) of evaluation of this end point: Evaluation of hair growth will be performed on day 87. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline of total hair density (No. of hairs per cm2) on the scalp after 8 weeks of treatment. Change from baseline of hair growth parameters after 8 and 12 weeks of treatment: • Cumulative hair thickness (mm/cm²) • Hair thickness (µm/cm², mean median) • Hair length (mm/cm2; mean, median) • Terminal hair density (n/cm2) • Vellus hair (<40µm thick) density (n/cm2) • Total hair growth (µm/day/cm2) • Hair growth (µm/day/cm2, mean median) • TrichoScan Anagen/Telogen ratio • Proportion of anagen hairs (%) • Proportion of telogen hairs (%) • Proportion of vellus hair (%) To evaluate the safety based on: • Any adverse events • Any adverse drug reactions • Local tolerability • Vital signs and physical examination • Abnormal safety laboratory parameters ; Timepoint(s) of evaluation of this end point: Evaluation of hair growth will be performed after 8 and 12 weeks. Adverse events and local tolerability will be assessed continously during the trial. Vital signs, physical examination and laboratory parameters will be evaluated at End of Trial. | — |
Countries
Germany
Contacts
Public ContactJan Alenfall
Follicum AB
Outcome results
None listed