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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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: NCT00687908 |
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Recruitment Status :
Completed
First Posted : June 2, 2008
Results First Posted : September 24, 2010
Last Update Posted : October 5, 2010
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Sponsor:
Galderma
Information provided by:
Galderma
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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 |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
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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 |
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Placebo Comparator: 2
Vehicle Gel once daily
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Drug: Vehicle Gel
Topical Gel to the face, once daily in the evening for 24 weeks. |
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
- Almost Clear:A few scattered comedones & a few small papules.
- Mild:Some comedones & some papules and pustules. No nodules present
- Moderate:Many comedones, papules & pustules. One nodule may be present
- Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
- 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
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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
Hide Study Locations
Locations
| 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
| Principal Investigator: | Diane Thiboutot, MD | Penn State College of Medicine, Hershey, PA |
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 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:
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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 |