Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
Hypertrichosis, Alopecia, Hirsutism
About this trial
This is an interventional treatment trial for Hypertrichosis
Eligibility Criteria
Inclusion Criteria:
- Healthy male, aged 18-45 years
- Clinically visible terminal hair growth on thighs
Exclusion Criteria:
- Damaged skin in or around test sites
- History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial
- History or clinical signs of keloids or hypertrophic scars
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus
- 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)
- Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks
- Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens
- Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors
- Current or within one week prior to first dosing use of any topical drugs on the legs
Sites / Locations
- Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo
FOL-005: Solution 1
FOL-005: Solution 2
FOL-005: Solution 3
FOL-005: Solution 4
Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.