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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.

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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:

  1. Subjects with a minimum of 20 inflammatory lesions on the face;
  2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
  3. 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 No
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.




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