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Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)

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: NCT00883233
Recruitment Status : Completed
First Posted : April 17, 2009
Results First Posted : December 8, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Galderma

Tracking Information
First Submitted Date  ICMJE April 16, 2009
First Posted Date  ICMJE April 17, 2009
Results First Submitted Date  ICMJE October 11, 2010
Results First Posted Date  ICMJE December 8, 2010
Last Update Posted Date December 8, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2010)
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. [ Time Frame: Week 4 ]
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2009)
Local tolerability will be analyzed in terms of worsening from Baseline with maximum severity reached. [ Time Frame: Baseline, W2, W4, W8, W12/Early termination ]
Change History Complete list of historical versions of study NCT00883233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Official Title  ICMJE Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Brief Summary The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: Adapalene BPO Gel standard daily overnight application
    Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
    Other Name: Standard
  • Drug: Adapalene-BPO 3-hour daily application before bedtime
    Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
    Other Name: 3-hour before bedtime
  • Drug: Adapalene-BPO Gel every other day application
    Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
    Other Name: every other day
  • Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
    Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
    Other Name: Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion
Study Arms  ICMJE
  • Experimental: 1
    Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
    Intervention: Drug: Adapalene-BPO 3-hour daily application before bedtime
  • Experimental: 2
    Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
    Intervention: Drug: Adapalene-BPO Gel every other day application
  • Experimental: 3
    Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
    Intervention: Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
  • Active Comparator: 4
    Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
    Intervention: Drug: Adapalene BPO Gel standard daily overnight application
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: November 5, 2009)
123
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2009)
120
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female Subjects of any race, aged 12 to 35 years inclusive
  • Subjects with mild or moderate facial acne vulgaris
  • Subjects with skin phototype I to IV

Exclusion Criteria:

  • Subjects with more than 1 nodules or cysts on the face,
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00883233
Other Study ID Numbers  ICMJE RD.03.SPR.29085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean-Charles DHUIN Clinical Trial Manager, Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jerry Tan, MD Windsor, ON, Canada
PRS Account Galderma
Verification Date November 2010

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