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

Acne Clinical Trial

— ACCESS II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687908
• Other study ID #: RD.03.SPR.29075
• Status: Completed
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Topical Gel to the face, once daily in the evening for 24 weeks.
• Vehicle Gel
Topical Gel to the face, once daily in the evening for 24 weeks.

Locations

Country	Name	City	State
Canada	Galderma Investigational Site	Barrie	Ontario
Canada	Galderma Investigational Site	North Bay	Ontario
Canada	Galderma Investigational Site	Quebec City	Quebec
Canada	Galderma Investigational Site	Windsor	Ontario
Puerto Rico	Galderma Investigational Site	Aibonito
Puerto Rico	Galderma Investigational Site	Carolina
United States	Galderma Investigational Site	Albuquerque	New Mexico
United States	Galderma Investigational Site	Arlington	Texas
United States	Galderma Investigational Site	Austin	Texas
United States	Galderma Investigational Site	Chicago	Illinois
United States	Galderma Investigational Site	College Station	Texas
United States	Galderma Investigational Site	Denver	Colorado
United States	Galderma Investigational Site	Detroit	Michigan
United States	Galderma Investigational Site	Evansville	Indiana
United States	Galderma Investigational Site	Fort Gratiot	Michigan
United States	Galderma Investigational Site	Fridley	Minnesota
United States	Galderma Investigational Site	Hazleton	Pennsylvania
United States	Galderma Investigational Site	Hershey	Pennsylvania
United States	Galderma Investigational Site	Houston	Texas
United States	Galderma Investigational Site	Longmont	Colorado
United States	Galderma Investigational Site	Louisville	Kentucky
United States	Galderma Investigational Site	Lubbock	Texas
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	Omaha	Nebraska
United States	Galderma Investigational Site	Overland Park	Kansas
United States	Galderma Investigational Site	San Antonio	Texas
United States	Galderma Investigational Site	San Diego	California
United States	Galderma Investigational Site	Simpsonville	South Carolina
United States	Galderma Investigational Site	Snellville	Georgia
United States	Galderma Investigational Site	Stony Brook	New York
United States	Galderma Investigational Site	Warren	Ohio
United States	Galderma Investigational Site	Webster	Texas
United States	Galderma Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance Success for Total Lesions at 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.	Week 24
Secondary	Maintenance Success for Inflamatory Lesions at 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.	Week 24
Secondary	Maintenance Success for Non-inflammatory Lesions at 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.	Week 24
Secondary	Investigator Global Assessment (IGA) Maintenance Success at 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	Baseline, Week 24
Secondary	Percent of Subjects With Adverse Events	All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent	Up to 24 weeks

External Links

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