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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Follicum AB
• Treatments: Pharmaceutical Solutions

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