At a glance
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A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers
In Brief
A Phase 2 clinical trial evaluating FOL-005 and Placebo for Androgenic Alopecia. Completed, enrolled 60 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
intradermal injection
intradermal injection