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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687908
First Posted: June 2, 2008
Last Update Posted: October 5, 2010
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.
Information provided by:
Galderma
  Purpose
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.

Condition Intervention Phase
Acne Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Drug: Vehicle Gel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 243
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
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
Placebo Comparator: 2
Vehicle Gel once daily
Drug: Vehicle Gel
Topical Gel to the face, once daily in the evening for 24 weeks.

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"
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687908


  Show 33 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Diane Thiboutot, MD Penn State College of Medicine, Hershey, PA
  More Information

Additional Information:
Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00687908     History of Changes
Other Study ID Numbers: RD.03.SPR.29075
First Submitted: May 28, 2008
First Posted: June 2, 2008
Results First Submitted: July 16, 2010
Results First Posted: September 24, 2010
Last Update Posted: October 5, 2010
Last Verified: September 2010

Keywords provided by Galderma:
Acne

Additional relevant MeSH terms:
Benzoyl Peroxide
Adapalene
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents