A Twelve Week Safety and Efficacy Study in Rosacea
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
Lead SponsorCutanea Life Sciences, Inc.
StatusCompleted No Results Posted
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
omiganan mid dose once daily application for 12 weeks
omiganan high dose once daily application for 12 weeks
Vehicle once daily application for 12 weeks
omiganan low dose once daily application for 12 weeks
Inclusion Criteria: diagnosis of papulopustular rosacea (at least 15 lesions) Exclusion Criteria: nodular rosacea or subtype 3 clinically significant abnormal findings that would interfere with study objectives