Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%; Drug: Adapalene Gel, 0.1%; Drug: Tazarotene Cream, 0.1%

• Registration Number: NCT00469755
• Lead Sponsor: Galderma R&D

Brief Summary

To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Detailed Description

Same as above.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Status Verified: 2008-03
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
• Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria

• Subjects with more than 3 nodulo-cystic lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
3	Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%	Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks
1	Adapalene Gel, 0.1%	Differin® Gel, 0.1% for 12 weeks
2	Tazarotene Cream, 0.1%	Tazorac® Cream, 0.1% for 12 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy - total lesion counts	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety - tolerability assessments and adverse event reporting	12 weeks

Trial Locations

Locations (12)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Henry Ford Medical Center-Dept. of Dermatology; 🇺🇸 Detroit, Michigan, United States

State University of New York Downstate Medical Center-Dept. of Dermatology; 🇺🇸 Brooklyn, New York, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Phoebe Rich, MD & Associates; 🇺🇸 Portland, Oregon, United States

Dermatology Research Associates; 🇺🇸 Cincinnati, Ohio, United States

Milton S. Hershey Medical Center Center-Div. of Dermatology; 🇺🇸 Hershey, Pennsylvania, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

J & S Studies, Inc.; 🇺🇸 Bryan, Texas, United States

Stephens & Associates; 🇺🇸 Carrollton, Texas, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Dermatology Research Center; 🇺🇸 Salt Lake City, Utah, United States