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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

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.

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

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"

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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

  4. 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



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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).

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


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Locations
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United States, California
Galderma Investigational Site
San Diego, California, United States
United States, Colorado
Galderma Investigational Site
Denver, Colorado, United States
Galderma Investigational Site
Longmont, Colorado, United States
United States, Florida
Galderma Investigational Site
Miami, Florida, United States
United States, Georgia
Galderma Investigational Site
Snellville, Georgia, United States
United States, Illinois
Galderma Investigational Site
Chicago, Illinois, United States
United States, Indiana
Galderma Investigational Site
Evansville, Indiana, United States
United States, Kansas
Galderma Investigational Site
Overland Park, Kansas, United States
United States, Kentucky
Galderma Investigational Site
Louisville, Kentucky, United States
United States, Michigan
Galderma Investigational Site
Detroit, Michigan, United States
Galderma Investigational Site
Fort Gratiot, Michigan, United States
United States, Minnesota
Galderma Investigational Site
Fridley, Minnesota, United States
United States, Nebraska
Galderma Investigational Site
Omaha, Nebraska, United States
United States, New Mexico
Galderma Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Galderma Investigational Site
Stony Brook, New York, United States
United States, North Carolina
Galderma Investigational Site
Winston Salem, North Carolina, United States
United States, Ohio
Galderma Investigational Site
Warren, Ohio, United States
United States, Pennsylvania
Galderma Investigational Site
Hazleton, Pennsylvania, United States
Galderma Investigational Site
Hersey, Pennsylvania, United States
United States, South Carolina
Galderma Investigational Site
Simpsonville, South Carolina, United States
United States, Texas
Galderma Investigational Site
Arlington, Texas, United States
Galderma Investigational Site
Austin, Texas, United States
Galderma Investigational Site
College Station, Texas, United States
Galderma Investigational Site
Houston, Texas, United States
Galderma Investigational Site
Lubbock, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
Webster, Texas, United States, 77598
Canada, Ontario
Galderma Investigational Site
Barrie, Ontario, Canada
Galderma Investigational Site
North Bay, Ontario, Canada
Galderma Investigational Site
Windsor, Ontario, Canada
Canada, Quebec
Galderma Investigational Site
Quebec City, Quebec, Canada
Puerto Rico
Galderma Investigational Site
Aibonito, Puerto Rico
Galderma Investigational Site
Carolina, Puerto Rico
Sponsors and Collaborators
Galderma
Investigators
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Principal Investigator: Diane Thiboutot, MD Penn State College of Medicine, Hershey, PA

Additional Information:
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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 Posted: June 2, 2008    Key Record Dates
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:
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Acne Vulgaris
Benzoyl Peroxide
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
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