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

February 16, 2021 updated by: Galderma R&D

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

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1075

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
        • The Dermatology Centre
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical
    • British Columbia
      • Surrey, British Columbia, Canada, T3A2N1
        • Guildford Dermatology Specialists
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1R4
        • Dermadvance Research
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
        • Nexus Clinical Research
    • Ontario
      • Markham, Ontario, Canada, L3P 6L2
        • Lynderm Research, Inc.
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research, Inc.
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
      • Little Rock, Arkansas, United States, 72205
        • Scott Dinehart
    • California
      • Marina Del Rey, California, United States, 90292
        • Dermatology and Laser Center
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • Vallejo, California, United States, 94589
        • Solano Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center
      • Longmont, Colorado, United States, 80501
        • Longmont Clinic
    • Florida
      • Clermont, Florida, United States, 34711
        • Advanced Dermatology
      • Miami, Florida, United States, 33144
        • International Dermatology Research, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Anne M. Loebl
    • Illinois
      • Buffalo Grove, Illinois, United States, 60089
        • Scott Glazer
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Sound Bend Clinic
    • Michigan
      • Port Huron, Michigan, United States, 48060
        • Hamzavi Dermatology
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology, PC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Darmouth-Hitchcock Medical Center Section of Dermatology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology
    • New York
      • Rochester, New York, United States, 14609
        • Elizabeth Arthur
      • Stony Brook, New York, United States, 11790
        • Derm Research Center of New York
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Unifour Medical Research Associates
    • Ohio
      • South Euclid, Ohio, United States, 44118
        • Haber Dermatology & Cosmetic Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Sciences Center-Dept. of Dermatology
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Center, PC
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Houston, Texas, United States, 77058
        • Center for Clinical Studies
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapalene lotion 0.1%
Drug: Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Placebo Comparator: Adapalene Lotion vehicle
Drug: Adapalene Lotion Vehicle
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Time Frame: 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.
From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Time Frame: From Baseline to Week 12
Percent change in lesion count from baseline to week 12
From Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18113
  • IND 076057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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