To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
Status:
Completed
Trial end date:
2018-08-22
Target enrollment:
Participant gender:
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.