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

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793557
• Other study ID #: FCS-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2016
• Last updated: July 29, 2017
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Follicum AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Hirsutism
• Hypertrichosis

Intervention

Drug:
• FOL-005
Intradermal injection of 50 µl solution

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Follicum AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects		3 months
Secondary	Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2		3 months
Secondary	Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs		3 months
Secondary	Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs		3 months