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Trial record 31 of 136 for:    acne AND peroxide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00671749
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE April 30, 2008
First Posted Date  ICMJE May 5, 2008
Results First Submitted Date  ICMJE August 12, 2014
Results First Posted Date  ICMJE March 16, 2016
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
Percent Change From Baseline in Total Lesion Counts [ Time Frame: 6 and 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
Percent change from baseline in total lesion counts at Week 12 [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00671749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Global Severity Assessment Success [ Time Frame: 6 and 12 weeks ]
    Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
  • Global Assessment of Improvement From Baseline [ Time Frame: 12 weeks ]
  • Worst Post Baseline Tolerability Assessment - Erythema [ Time Frame: 12 weeks ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment - Scaling [ Time Frame: 12 weeks ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment - Dryness [ Time Frame: 12 weeks ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
  • Worst Post Baseline Tolerability Assessment - Burning/Stinging [ Time Frame: 12 weeks ]
    Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
  • Percent change from baseline in total lesion counts at Week 6 [ Time Frame: 6 weeks ]
  • Percent change from baseline in inflammatory and non-inflammatory lesion counts at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ]
  • Global severity assessment at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ]
  • Global assessment of Improvement from baseline at Week 12 [ Time Frame: 12 weeks ]
  • Tolerability assessments and incidence of adverse events [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: adapalene gel, 0.3%
    Applied once daily at bedtime
    Other Name: Differin® Gel, 0.3%
  • Drug: clindamycin/benzoyl peroxide gel
    Applied once daily in the morning
    Other Name: Duac® Gel
Study Arms  ICMJE Experimental: Study Treatment

adapalene gel, 0.3%

Other Names:

Differin® Gel, 0.3% Applied once daily at bedtime

clindamycin/benzoyl peroxide gel

Other Names:

Duac® Gel Applied once daily in the morning

Interventions:
  • Drug: adapalene gel, 0.3%
  • Drug: clindamycin/benzoyl peroxide gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00671749
Other Study ID Numbers  ICMJE US10066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ron W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date February 2016

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