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A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
This study has been completed.
Study NCT00421993   Information provided by Galderma
First Received: January 11, 2007   Last Updated: October 19, 2009   History of Changes

January 11, 2007
October 19, 2009
October 2006
October 2007   (final data collection date for primary outcome measure)
  • Success Rate on the Investigator's Global Assessment [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Changes in Inflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
  • Changes in Noninflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
  • Success Rate on the Investigator’s Global Assessment
  • Change in Inflammatory Lesion Counts
  • Change in Noninflammatory Lesion Counts
Complete list of historical versions of study NCT00421993 on ClinicalTrials.gov Archive Site
  • Percent Change in Inflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Percent Change in Noniflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Percent Change in Total Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Percent Change in Lesion Counts (Inflammatory,Noninflammatory, Total)
  • Change in Investigator’s Global Assessment (IGA)
  • Subject’s Assessment of Acne
 
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Acne Vulgaris
  • Drug: Adapalene/Benzoyl Peroxide
  • Drug: Adapalene
  • Drug: Benzoyl Peroxide
  • Drug: Topical Gel Vehicle
  • Experimental: Adapalene/Benzoyl Peroxide Topical Gel
  • Active Comparator: Adapalene Topical Gel
  • Active Comparator: Benzoyl Peroxide Topical Gel
  • Placebo Comparator: Topical Gel Vehicle
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1670
December 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions
  • A minimum of 30 but not more than 100 Noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

  • More than one acne nodule or any acne cyst.
  • Acne conglobata, acne fulminans, secondary acne, or severe acne.
  • Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
  • Underlying diseases that require the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period is documented
  • Use of hormonal contraceptives solely for control of acne
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Hungary,   Poland
 
NCT00421993
Michael Graeber, MD, Head of US Development, Galderma
RD.06.SPR.18088
Galderma
 
Study Director: Michael Graeber, MD Galderma
Galderma
October 2009

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