NCT03467412

To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin

A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Follicum AB · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial. 60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion. The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair. The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.

Conditions

• Androgenic Alopecia

Interventions

Type	Name	Description
DRUG	FOL-005	intradermal injection
DRUG	Placebo	intradermal injection

Timeline

• Start date: 2018-02-27
• Primary completion: 2018-08-22
• Completion: 2018-08-22
• First posted: 2018-03-16
• Last updated: 2020-12-03
• Results posted: 2020-12-03

Locations

2 sites across 1 country: Germany