NCT00689117

A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,649 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Detailed description

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Conditions

• Acne Vulgaris
• Acne

Interventions

Type	Name	Description
DRUG	CT Gel	Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
DRUG	Clindamycin Gel (clindamycin )	Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
DRUG	Tretinoin Gel (tretinoin)	Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
DRUG	Vehicle Gel	Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-06-03
• Last updated: 2017-05-30
• Results posted: 2010-12-02

Locations

32 sites across 3 countries: United States, Belize, Canada