NCT02791243

Photosensitization Study in Androgenetic Alopecia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Polichem S.A. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Finasteride 0.25%	Cutaneous solution of finasteride 0.25%
DRUG	Placebo for Finasteride 0.25%	vehicle cutaneous solution of P-3074
DRUG	Negative Control	0.9% aqueous NaCl

Timeline

• Start date: 2016-05-09
• Primary completion: 2016-06-01
• Completion: 2016-06-27
• First posted: 2016-06-06
• Last updated: 2017-05-18

Locations

1 site across 1 country: United Kingdom