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

Phase 1

Completed

• Conditions: Hypertrichosis; Alopecia; Hirsutism
• Interventions: Drug: FOL-005; Other: Placebo

• Registration Number: NCT02793557
• Lead Sponsor: Follicum AB

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-29
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOL-005: Solution 3	FOL-005	Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
FOL-005: Solution 1	FOL-005	Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Placebo	Placebo	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.
FOL-005: Solution 2	FOL-005	Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
FOL-005: Solution 4	FOL-005	Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin; 🇩🇪 Berlin, Germany