NCT02793557

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Follicum AB · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	FOL-005	Intradermal injection of 50 μl solution
OTHER	Placebo

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-06-08
• Last updated: 2017-08-01

Locations

1 site across 1 country: Germany