Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance - Full Text View

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:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

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:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013

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