search
Back to results

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

Primary Purpose

Acne

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily

Vehicle Gel once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
May 28, 2008
Last Updated
February 16, 2021
Sponsor
Galderma R&D
search

1. Study Identification

Unique Protocol Identification Number
NCT00687908
Brief Title
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel once daily
Intervention Type
Drug
Intervention Name(s)
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Other Intervention Name(s)
Adapalene-BPO gel
Intervention Description
Topical Gel to the face, once daily in the evening for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Topical Gel to the face, once daily in the evening for 24 weeks.
Primary Outcome Measure Information:
Title
Maintenance Success for Total Lesions at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Maintenance Success for Inflamatory Lesions at Week 24
Description
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.
Time Frame
Week 24
Title
Maintenance Success for Non-inflammatory Lesions at Week 24
Description
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.
Time Frame
Week 24
Title
Investigator Global Assessment (IGA) Maintenance Success at Week 24
Description
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
Time Frame
Baseline, Week 24
Title
Percent of Subjects With Adverse Events
Description
All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Thiboutot, MD
Organizational Affiliation
Penn State College of Medicine, Hershey, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galderma Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Galderma Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Galderma Investigational Site
City
Longmont
State/Province
Colorado
Country
United States
Facility Name
Galderma Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Galderma Investigational Site
City
Snellville
State/Province
Georgia
Country
United States
Facility Name
Galderma Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Galderma Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Galderma Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Galderma Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Galderma Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Galderma Investigational Site
City
Fort Gratiot
State/Province
Michigan
Country
United States
Facility Name
Galderma Investigational Site
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Galderma Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Galderma Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Galderma Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Galderma Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Galderma Investigational Site
City
Warren
State/Province
Ohio
Country
United States
Facility Name
Galderma Investigational Site
City
Hazleton
State/Province
Pennsylvania
Country
United States
Facility Name
Galderma Investigational Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Galderma Investigational Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Galderma Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
College Station
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
Lubbock
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Galderma Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Galderma Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Galderma Investigational Site
City
North Bay
State/Province
Ontario
Country
Canada
Facility Name
Galderma Investigational Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Galderma Investigational Site
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Galderma Investigational Site
City
Aibonito
Country
Puerto Rico
Facility Name
Galderma Investigational Site
City
Carolina
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
http://galderma.com/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs