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

Tracking Information

First Received Date ^ICMJE

May 2, 2007

Last Updated Date

March 28, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy - total lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Percent reduction in total lesion count.

Change History

Complete list of historical versions of study NCT00469755 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety - tolerability assessments and adverse event reporting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: Adapalene Gel, 0.1%
Drug: Tazarotene Cream, 0.1%
Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

Study Arms / Comparison Groups

Active Comparator: Differin® Gel, 0.1% for 12 weeks
Active Comparator: Tazorac® Cream, 0.1% for 12 weeks
Active Comparator: Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

302

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00469755

Responsible Party

Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.

Study ID Numbers ^ICMJE

US10026

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP