Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth (NCT02793557) | Clinical Trial Compass
CompletedPhase 1/2
Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
Germany44 participantsStarted 2016-01
Plain-language summary
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
Who can participate
Age range18 Years – 45 Years
SexMALE
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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
What they're measuring
1
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects