Clinical Trial: Photosensitization Study in Androgenetic Alopecia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Within-subject, Randomized, Evaluator-blinded, Vehicle-controlled Study to Assess the Photosensitization Potential of Finasteride Cutaneous Solution(P-3074) in Human Subjects

Brief Summary: This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl)

Detailed Summary: Healthy male volunteers, drawn from the general population, will be treated with P-3074 solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6 induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB) irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of photosensitization over the subsequent 72 hours.
Sponsor: Polichem S.A.

Current Primary Outcome: Potential for induction of photosensitization [ Time Frame: from day 4 to day 42 ]

Original Primary Outcome: Skin Visual Assessment Scores [ Time Frame: from day 4 to day 42 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Polichem S.A.

Dates:
Date Received: June 1, 2016
Date Started: May 9, 2016
Date Completion:
Last Updated: May 17, 2017
Last Verified: May 2017