search
Back to results

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Primary Purpose

Acne Vulgaris

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

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Adapalene, Benzoyl Peroxide

Eligibility Criteria

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

Inclusion Criteria:

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions
  • A minimum of 30 but not more than 100 Noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

  • More than one acne nodule or any acne cyst.
  • Acne conglobata, acne fulminans, secondary acne, or severe acne.
  • Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
  • Underlying diseases that require the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period is documented
  • Use of hormonal contraceptives solely for control of acne

Sites / Locations

  • Medical Affliated Research Center
  • Dermatology Research of Arkansas
  • Associates in research, Inc.
  • University of California, Irvine
  • Dermatology Research Associates
  • Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
  • Affiliated Research Institute
  • University at San Francisco Medical Center
  • Radiant Research
  • Dr Weintraub James
  • The George Washington University Medical Center
  • Visions Clinical Research
  • Atlanta Dermatology and Vein Research Center
  • SKINQRI
  • Welborn Clinic
  • Dawes Fretzin Clinical Research Group, LLC
  • Dolby Research, LLC
  • Hamzavi Dermatology
  • Somerset Skin Clinic
  • James Del Rosso, DO - Office of Dr. James Del Russo
  • Dartmouth-Hitchcock Medical Center
  • Skin Specialty Group
  • Derm Research Center of NY, Inc.
  • Zoe Draelos
  • OU Health Sciences Center - Dept. of Dermatology
  • Allergy, Asthma and Dermatology Research Center, LLC
  • Radiant Research
  • Dermatology Associates of Knoxville
  • Arlington Center for Dermatology
  • UTSW Medical Center at Dallas
  • University of Texas Medical Branch at Galveston
  • Tanner Clinic
  • Fletcher Allen Health Care
  • The Dermatology Centre
  • Stratica Medical
  • Guildford Dermatology Specialists
  • Derm Research @ 888 Inc.
  • Winnipeg Clinic
  • Dermadvances Research
  • Nexus clinical research
  • NewLab Clinical Research
  • Ultranova Skin care
  • Lynderm Research inc.
  • North Bay Dermatology Centre
  • XLR8 Medical Research Inc.
  • Innovaderm Research Laval Inc.
  • Innovaderm Research Inc
  • Siena Medical Research
  • Licca Clinical Research Institute
  • Henrik Pres
  • Meike Schroeder
  • Beatrice Gerlach
  • Kloverkorn, Windfried
  • Otto-Von-Guericke-Universitat Magdeburg
  • Michael Sebastian
  • Thomas Dirschka
  • Outpatient Dermatology Department DUH
  • Margit Simola
  • Outpatient Dermatilogy Department XIX District
  • Waldemar Placek
  • DERMED Specjalistyczne Gabinety Lekarskie
  • Wojceiech Silny

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Adapalene/Benzoyl Peroxide Topical Gel

Adapalene Topical Gel

Benzoyl Peroxide Topical Gel

Topical Gel Vehicle

Outcomes

Primary Outcome Measures

Success Rate on the Investigator's Global Assessment
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Changes in Inflammatory Lesion Counts
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Changes in Noninflammatory Lesion Counts
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

Secondary Outcome Measures

Percent Change in Inflammatory Lesion Counts
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Noniflammatory Lesion Counts
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Total Lesion Counts
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Full Information

First Posted
January 11, 2007
Last Updated
February 16, 2021
Sponsor
Galderma R&D
search

1. Study Identification

Unique Protocol Identification Number
NCT00421993
Brief Title
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Galderma R&D

4. Oversight

5. Study Description

Brief Summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, Adapalene, Benzoyl Peroxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adapalene/Benzoyl Peroxide Topical Gel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Adapalene Topical Gel
Arm Title
3
Arm Type
Active Comparator
Arm Description
Benzoyl Peroxide Topical Gel
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Topical Gel Vehicle
Intervention Type
Drug
Intervention Name(s)
Adapalene/Benzoyl Peroxide
Intervention Description
Topical Gel, One application daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene
Intervention Description
Topical Gel,One application daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Benzoyl Peroxide
Intervention Description
Topical Gel, one application daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Topical Gel Vehicle
Intervention Description
Topical Gel Vehicle,one application daily in the evening for 12 weeks
Primary Outcome Measure Information:
Title
Success Rate on the Investigator's Global Assessment
Description
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Time Frame
at week 12
Title
Changes in Inflammatory Lesion Counts
Description
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Time Frame
from Baseline to week 12
Title
Changes in Noninflammatory Lesion Counts
Description
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Time Frame
from Baseline to week 12
Secondary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesion Counts
Description
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame
at week 12
Title
Percent Change in Noniflammatory Lesion Counts
Description
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame
at week 12
Title
Percent Change in Total Lesion Counts
Description
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical diagnosis of acne vulgaris with facial involvement. A minimum of 20 but not more than 50 Inflammatory lesions A minimum of 30 but not more than 100 Noninflammatory lesions A score of 3 (Moderate) on the Investigator's Global Assessment Scale. Exclusion Criteria: More than one acne nodule or any acne cyst. Acne conglobata, acne fulminans, secondary acne, or severe acne. Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial. Underlying diseases that require the use of interfering topical or systemic therapy. Use of prohibited medications prior to the study unless appropriate washout period is documented Use of hormonal contraceptives solely for control of acne
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Dermatology Research of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Associates in research, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-1385
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
University at San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Dr Weintraub James
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
The George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Visions Clinical Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Atlanta Dermatology and Vein Research Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
SKINQRI
City
Lincolnshire
State/Province
Illinois
ZIP/Postal Code
60069
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dolby Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Hamzavi Dermatology
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Somerset Skin Clinic
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
James Del Rosso, DO - Office of Dr. James Del Russo
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Skin Specialty Group
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Derm Research Center of NY, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-2598
Country
United States
Facility Name
Zoe Draelos
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
OU Health Sciences Center - Dept. of Dermatology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Allergy, Asthma and Dermatology Research Center, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Radiant Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Dermatology Associates of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
UTSW Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9190
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
The Dermatology Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Guildford Dermatology Specialists
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
BC V3R 6A7
Country
Canada
Facility Name
Derm Research @ 888 Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
Facility Name
Winnipeg Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Dermadvances Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
Facility Name
Nexus clinical research
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
NewLab Clinical Research
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 4S8
Country
Canada
Facility Name
Ultranova Skin care
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Lynderm Research inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
XLR8 Medical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Innovaderm Research Laval Inc.
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7S 2C6
Country
Canada
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Siena Medical Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1C6
Country
Canada
Facility Name
Licca Clinical Research Institute
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Henrik Pres
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
Meike Schroeder
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Beatrice Gerlach
City
Dresden
ZIP/Postal Code
01097
Country
Germany
Facility Name
Kloverkorn, Windfried
City
Gilching
ZIP/Postal Code
82205
Country
Germany
Facility Name
Otto-Von-Guericke-Universitat Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Michael Sebastian
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Thomas Dirschka
City
Wuppertal
ZIP/Postal Code
42275
Country
Germany
Facility Name
Outpatient Dermatology Department DUH
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Margit Simola
City
Budapest
ZIP/Postal Code
1084
Country
Hungary
Facility Name
Outpatient Dermatilogy Department XIX District
City
Budapest
ZIP/Postal Code
1195
Country
Hungary
Facility Name
Waldemar Placek
City
Bydgoszcz
ZIP/Postal Code
85096
Country
Poland
Facility Name
DERMED Specjalistyczne Gabinety Lekarskie
City
Lodz
ZIP/Postal Code
90265
Country
Poland
Facility Name
Wojceiech Silny
City
Poznan
ZIP/Postal Code
60355
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
12963896
Citation
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.
Results Reference
background
Links:
URL
http://www.galderma.com/
Description
Related Info

Learn more about this trial

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

We'll reach out to this number within 24 hrs