Trial | NCT02793557  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fol-005 ...

  • Study Participants

    44
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.
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 Started
Jan 31
2016
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Aug 01
2017

Drug FOL-005

Intradermal injection of 50 μl solution

Other Placebo

Placebo Placebo Comparator

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 1 Experimental

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 2 Experimental

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 3 Experimental

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 Experimental

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

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
No Results Posted