Alopecia, Hirsutism, Hypertrichosis
Conditions
Brief 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.
Detailed description
SAD part: A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3. MD part: In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
Interventions
DRUGFOL-005
Intradermal injection of 50 μl solution
OTHERPlacebo
Sponsors
Follicum AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2 | 3 months |
| Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs | 3 months |
| Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs | 3 months |
Countries
Germany
Outcome results
None listed