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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00687908
First received: May 28, 2008
Last updated: September 30, 2010
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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.
Other Name: Vehicle gel

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

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00687908     History of Changes
Other Study ID Numbers: RD.03.SPR.29075
Study First Received: May 28, 2008
Results First Received: July 16, 2010
Last Updated: September 30, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Galderma:
Acne

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

ClinicalTrials.gov processed this record on October 20, 2014