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Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (ACCESS I)

Primary Purpose

Severe Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adapalene BPO Gel associated with Doxycyline Hyclate
Vehicle Gel associated with Doxycycline Hyclate
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female Subjects of any race, aged 12 to 35 years inclusive
  • Subjects with severe facial acne (global severity score of 4)
  • Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
  • Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

  • Subjects with more than 3 nodules or cysts on the face,
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, 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
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Adapalene-BPO + Doxycyline

Vehicle + Doxycycline

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Total Lesion Counts at Week 12.

Secondary Outcome Measures

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Success Rate on the Investigator's Global Assessment
Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
Percent of Subjects With Adverse Events
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)

Full Information

First Posted
May 28, 2008
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00688064
Brief Title
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Acronym
ACCESS I
Official Title
Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 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 (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Detailed Description
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adapalene-BPO + Doxycyline
Arm Title
2
Arm Type
Active Comparator
Arm Description
Vehicle + Doxycycline
Intervention Type
Drug
Intervention Name(s)
Adapalene BPO Gel associated with Doxycyline Hyclate
Other Intervention Name(s)
Adapalene-BPO gel + Doxycycline
Intervention Description
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel associated with Doxycycline Hyclate
Other Intervention Name(s)
Vehicle gel + Doxycycline
Intervention Description
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total Lesion Counts at Week 12.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Time Frame
Week 12
Title
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Time Frame
Week 12
Title
Success Rate on the Investigator's Global Assessment
Description
Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12
Time Frame
Week 12
Title
Percent of Subjects With Adverse Events
Description
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Time Frame
Up to 12 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: Male or female Subjects of any race, aged 12 to 35 years inclusive Subjects with severe facial acne (global severity score of 4) Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: Subjects with more than 3 nodules or cysts on the face, Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Stein Gold, MD
Organizational Affiliation
Henry Ford Medical Center-New Center One, Detroit, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galderma Investigational Site
City
Oceanside
State/Province
California
Country
United States
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://www.galderma.com
Description
Related Info

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Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

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