Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers

Conditions
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Hypertrichosis, Alopecia, Hirsutism

Intervention / Treatment
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* Drug: FOL-005
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br> <br> |
| Experimental: FOL-005: Solution 1<br>Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. | Drug: FOL-005<br>* Intradermal injection of 50 μl solution<br>|
| Experimental: FOL-005: Solution 2<br>Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. | Drug: FOL-005<br>* Intradermal injection of 50 μl solution<br>|
| Experimental: FOL-005: Solution 3<br>Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. | Drug: FOL-005<br>* Intradermal injection of 50 μl solution<br>|
| Experimental: FOL-005: Solution 4<br>Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. | Drug: FOL-005<br>* Intradermal injection of 50 μl solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |