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Trial record 18 of 134 for:    acne AND peroxide

Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (ACCESS II)

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ClinicalTrials.gov Identifier: NCT00687908
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : September 24, 2010
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Galderma

Tracking Information
First Submitted Date  ICMJE May 28, 2008
First Posted Date  ICMJE June 2, 2008
Results First Submitted Date  ICMJE July 16, 2010
Results First Posted Date  ICMJE September 24, 2010
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
Maintenance Success for Total Lesions at Week 24 [ Time Frame: Week 24 ]
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
Maintenance rate for total lesions at Week 24 : defined as the percentage of subjects maintaining at least 50% of the improvement obtained with prior combination therapy, in terms of total lesion counts. [ Time Frame: Week 24 ]
Change History Complete list of historical versions of study NCT00687908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
  • Maintenance Success for Inflamatory Lesions at Week 24 [ Time Frame: Week 24 ]
    Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.
  • Maintenance Success for Non-inflammatory Lesions at Week 24 [ Time Frame: Week 24 ]
    Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
  • Investigator Global Assessment (IGA) Maintenance Success at Week 24 [ Time Frame: Baseline, Week 24 ]
    IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade. IGA grade: 0 Clear:Residual hyperpigmentation & erythema may be present
    1. Almost Clear:A few scattered comedones & a few small papules.
    2. Mild:Some comedones & some papules and pustules. No nodules present
    3. Moderate:Many comedones, papules & pustules. One nodule may be present
    4. Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
    5. Very severe:Highly inflammatory acne covering the face; with nodules & cysts present
  • Percent of Subjects With Adverse Events [ Time Frame: Up to 24 weeks ]
    All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]
  • Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postiflammatory Hyperpigmentation Worst-score post Baseline. [ Time Frame: All along the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Official Title  ICMJE Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment
Brief Summary The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
Detailed Description This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
    Topical Gel to the face, once daily in the evening for 24 weeks.
    Other Name: Adapalene-BPO gel
  • Drug: Vehicle Gel
    Topical Gel to the face, once daily in the evening for 24 weeks.
Study Arms  ICMJE
  • Experimental: 1
    Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
    Intervention: Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
  • Placebo Comparator: 2
    Vehicle Gel once daily
    Intervention: Drug: Vehicle 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: August 26, 2010)
243
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2008)
280
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning a pregnancy during the study
  • Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, 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,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00687908
Other Study ID Numbers  ICMJE RD.03.SPR.29075
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: Diane Thiboutot, MD Penn State College of Medicine, Hershey, PA
PRS Account Galderma
Verification Date September 2010

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