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

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

This study has been completed.

Study NCT00671749. Last updated on September 5, 2008. Information provided by Galderma Laboratories, L.P.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Acne Vulgaris

Intervention ^†

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

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

100

Start Date ^†

December 2007

Completion Date

August 2008

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00671749

Organization ID

US10066

Secondary IDs ^††

Study Sponsor ^†

Galderma Laboratories, L.P.

Collaborators ^††

Investigators ^†

Study Director:

Ron W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

September 2008

First Received Date ^†

April 30, 2008

Last Updated Date

September 5, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.