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

Last updated: July 29, 2017
Sponsor: Follicum AB
Overall Status: Completed

Phase

1/2

Condition

Female Hormonal Deficiencies/abnormalities

Hair Loss

Male Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT02793557
FCS-001
  • Ages 18-45
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male, aged 18-45 years

  • Clinically visible terminal hair growth on thighs

Exclusion

Exclusion Criteria:

  • Damaged skin in or around test sites

  • History of any acute (e.g. acute infections) or chronic illness or known skin cancerthat 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, neworal 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 growthmodifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens

  • Current or within 12 months prior to first dosing intake of anabolics or 5-alphareductase inhibitors

  • Current or within one week prior to first dosing use of any topical drugs on the legs

Study Design

Total Participants: 44
Study Start date:
January 01, 2016
Estimated Completion Date:
March 31, 2017

Study 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.

Connect with a study center

  • Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

    Berlin, 10117
    Germany

    Site Not Available

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