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Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (ACCESS I)

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: NCT00688064
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : March 31, 2010
Last Update Posted : April 6, 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 February 23, 2010
Results First Posted Date  ICMJE March 31, 2010
Last Update Posted Date April 6, 2010
Study Start Date  ICMJE August 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2010)
  • Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. [ Time Frame: Week 12 ]
  • Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: Week 12 ]
  • Success Rate on the Investigator's Global Assessment [ Time Frame: Week 12 ]
    Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
  • Percent of Subjects With Adverse Events [ Time Frame: Up to 12 weeks ]
    Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • Percent change from Baseline in total lesion count at each intermediate visit, Percent change in inflammatory lesion count and in non-inflammatory lesion count at each post Baseline visit. [ Time Frame: Weeks 2, 4, 8 and 12 ]
  • Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI [ Time Frame: All along the study ]
  • Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination [ Time Frame: Weeks 2, 4, 8 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Official Title  ICMJE Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.
Brief Summary The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Detailed Description Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
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 Severe Acne Vulgaris
Intervention  ICMJE
  • Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
    Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
    Other Name: Adapalene-BPO gel + Doxycycline
  • Drug: Vehicle Gel associated with Doxycycline Hyclate
    Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
    Other Name: Vehicle gel + Doxycycline
Study Arms  ICMJE
  • Experimental: 1
    Adapalene-BPO + Doxycyline
    Intervention: Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
  • Active Comparator: 2
    Vehicle + Doxycycline
    Intervention: Drug: Vehicle Gel associated with Doxycycline Hyclate
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: January 6, 2009)
459
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2008)
440
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 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 severe facial acne (global severity score of 4)
  • Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
  • Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

  • Subjects with more than 3 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,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688064
Other Study ID Numbers  ICMJE RD.03.SPR.29074
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: Linda Stein Gold, MD Henry Ford Medical Center-New Center One, Detroit, MI
PRS Account Galderma
Verification Date March 2010

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