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Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adapalene lotion 0.1%
Adapalene Lotion 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

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with Moderate or Severe Acne Vulgaris,
  • 20-50 papules and pustules in total on the face excluding the nose
  • 30-100 non-inflammatory lesions on the face excluding the nose.
  • Negative urine pregnancy test for all females.

Exclusion Criteria:

  • Subjects with more than one acne nodule.
  • Subjects with any acne cyst on the face.
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
  • Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
  • Subjects who are pregnant, nursing, or planning a pregnancy.

Sites / Locations

  • Burke Pharmaceutical Research
  • Scott Dinehart
  • Dermatology and Laser Center
  • Therapeutics Clinical Research
  • Solano Clinical Research
  • Colorado Medical Research Center
  • Longmont Clinic
  • Advanced Dermatology
  • International Dermatology Research, Inc.
  • Anne M. Loebl
  • Scott Glazer
  • Sound Bend Clinic
  • Hamzavi Dermatology
  • Central Dermatology, PC
  • Darmouth-Hitchcock Medical Center Section of Dermatology
  • Academic Dermatology
  • Elizabeth Arthur
  • Derm Research Center of New York
  • Unifour Medical Research Associates
  • Haber Dermatology & Cosmetic Research
  • OU Health Sciences Center-Dept. of Dermatology
  • Oregon Medical Center, PC
  • Rivergate Dermatology
  • DermResearch, Inc.
  • Center for Clinical Studies
  • Progressive Clinical Research
  • Virginia Clinical Research, Inc.
  • The Dermatology Centre
  • Stratica Medical
  • Guildford Dermatology Specialists
  • Dermadvance Research
  • Nexus Clinical Research
  • Lynderm Research, Inc.
  • K. Papp Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adapalene lotion 0.1%

Adapalene Lotion vehicle

Arm Description

Outcomes

Primary Outcome Measures

Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12

Secondary Outcome Measures

Mean Percent Change in Total Lesion Count From Baseline to Week 12
Percent change in lesion count from baseline to week 12

Full Information

First Posted
January 11, 2008
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00598832
Brief Title
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (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 determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Detailed Description
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene lotion 0.1%
Arm Type
Experimental
Arm Title
Adapalene Lotion vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adapalene lotion 0.1%
Intervention Description
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene Lotion Vehicle
Intervention Description
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Primary Outcome Measure Information:
Title
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Description
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Time Frame
From Baseline to Week 12
Title
Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12
Time Frame
Baseline to Week 12
Title
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame
Baseline to Week 12
Title
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Description
Percent change in lesion count from baseline to week 12
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with Moderate or Severe Acne Vulgaris, 20-50 papules and pustules in total on the face excluding the nose 30-100 non-inflammatory lesions on the face excluding the nose. Negative urine pregnancy test for all females. Exclusion Criteria: Subjects with more than one acne nodule. Subjects with any acne cyst on the face. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. Subjects who are pregnant, nursing, or planning a pregnancy.
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Scott Dinehart
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Dermatology and Laser Center
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Longmont Clinic
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Advanced Dermatology
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Anne M. Loebl
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Scott Glazer
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Sound Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Hamzavi Dermatology
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Central Dermatology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Darmouth-Hitchcock Medical Center Section of Dermatology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Academic Dermatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Elizabeth Arthur
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Derm Research Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Unifour Medical Research Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Haber Dermatology & Cosmetic Research
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
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
Oregon Medical Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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
T3A2N1
Country
Canada
Facility Name
Dermadvance Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
Facility Name
Nexus Clinical Research
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Lynderm Research, Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 6L2
Country
Canada
Facility Name
K. Papp Clinical Research, Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

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