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

Acne Vulgaris Clinical Trial

Official title:

A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469755
• Other study ID #: US10026
• Status: Completed
• Phase: Phase 4
• Start date: February 2006
• Est. completion date: September 2006

Study information

• Verified date: March 2008
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Same as above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene Gel, 0.1%
Apply once daily in the evening for 12 weeks
• Tazarotene Cream, 0.1%
Apply once daily in the evening for 12 weeks
• Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	State University of New York Downstate Medical Center-Dept. of Dermatology	Brooklyn	New York
United States	J & S Studies, Inc.	Bryan	Texas
United States	Stephens & Associates	Carrollton	Texas
United States	Dermatology Research Associates	Cincinnati	Ohio
United States	Henry Ford Medical Center-Dept. of Dermatology	Detroit	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Milton S. Hershey Medical Center Center-Div. of Dermatology	Hershey	Pennsylvania
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Phoebe Rich, MD & Associates	Portland	Oregon
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - total lesion counts		12 weeks
Secondary	Safety - tolerability assessments and adverse event reporting		12 weeks