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

NCT ID: NCT02793557

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Hypertrichosis; Alopecia; Hirsutism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

FOL-005: Solution 1

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

Intradermal injection of 50 μl solution

FOL-005: Solution 2

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

Intradermal injection of 50 μl solution

FOL-005: Solution 3

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

Intradermal injection of 50 μl solution

FOL-005: Solution 4

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

Intradermal injection of 50 μl solution

Interventions

FOL-005

Intradermal injection of 50 μl solution

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Follicum AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrike Blume-Peytavi, Professor

Role: PRINCIPAL_INVESTIGATOR

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin

Locations

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Berlin, , Germany

Countries

Germany

Other Identifiers

FCS-001

Identifier Type: -

Identifier Source: org_study_id