Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris - Tabular View

Tracking Information

First Received Date ^ICMJE

April 30, 2008

Last Updated Date

September 5, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change from baseline in total lesion counts at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00671749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent change from baseline in total lesion counts at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in inflammatory and non-inflammatory lesion counts at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Global severity assessment at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Global assessment of Improvement from baseline at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tolerability assessments and incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Official Title ^ICMJE

A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Brief Summary

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Detailed Description

Same as above.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: adapalene gel, 0.3%
Drug: clindamycin/benzoyl peroxide gel

Study Arms / Comparison Groups

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

100

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with a minimum of 20 inflammatory lesions on the face;
Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three 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

NCT00671749

Responsible Party

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

Study ID Numbers ^ICMJE

US10066

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ron W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

September 2008

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