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

Sponsor

Galderma R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT00469755

Collaborator

(none)

302

Enrollment

Locations

Arms

Duration (Months)

25.2

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene Gel, 0.1% Drug: Tazarotene Cream, 0.1% Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%	Phase 4

Detailed Description

Same as above.

Study Design

Study Type:

Interventional

Actual Enrollment :

302 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Differin® Gel, 0.1% for 12 weeks	Drug: Adapalene Gel, 0.1% Apply once daily in the evening for 12 weeks Other Names: Differin® Gel, 0.1%
Active Comparator: 2 Tazorac® Cream, 0.1% for 12 weeks	Drug: Tazarotene Cream, 0.1% Apply once daily in the evening for 12 weeks Other Names: Tazorac® Cream, 0.1%
Active Comparator: 3 Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks	Drug: 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 Other Names: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

Arm

Intervention/Treatment

Active Comparator: 1

Differin® Gel, 0.1% for 12 weeks

Drug: Adapalene Gel, 0.1%

Apply once daily in the evening for 12 weeks

Other Names:

Differin® Gel, 0.1%

Active Comparator: 2

Tazorac® Cream, 0.1% for 12 weeks

Drug: Tazarotene Cream, 0.1%

Apply once daily in the evening for 12 weeks

Other Names:

Tazorac® Cream, 0.1%

Active Comparator: 3

Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Drug: 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

Other Names:

Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

Outcome Measures

Primary Outcome Measures

Efficacy - total lesion counts [12 weeks]

Secondary Outcome Measures

Safety - tolerability assessments and adverse event reporting [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Therapeutics Clinical Research	San Diego	California	United States	92123
2	Henry Ford Medical Center-Dept. of Dermatology	Detroit	Michigan	United States	48202
3	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
4	State University of New York Downstate Medical Center-Dept. of Dermatology	Brooklyn	New York	United States	11203
5	Dermatology Research Associates	Cincinnati	Ohio	United States	45230
6	Phoebe Rich, MD & Associates	Portland	Oregon	United States	97210
7	Milton S. Hershey Medical Center Center-Div. of Dermatology	Hershey	Pennsylvania	United States	17033-0850
8	DermResearch, Inc.	Austin	Texas	United States	78759
9	J & S Studies, Inc.	Bryan	Texas	United States	77802
10	Stephens & Associates	Carrollton	Texas	United States	75006
11	Dermatology Research Center	Salt Lake City	Utah	United States	84124
12	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

Galderma R&D

Investigators

Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00469755

Other Study ID Numbers:

US10026

First Posted:

May 4, 2007

Last Update Posted:

Jul 29, 2022

Last Verified:

Mar 1, 2008

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022