NCT01880320

Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The study hypothesis are based on the assumption that : * CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects * CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CD0271 0.3% / CD1579 2.5%
DRUG	CD0271 0.1% / CD1579 2.5%
DRUG	Topical Gel Vehicle

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-06-18
• Last updated: 2018-06-28
• Results posted: 2016-09-09

Locations

31 sites across 2 countries: United States, Canada