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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00599521
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Galderma

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE January 23, 2008
Results First Submitted Date  ICMJE April 16, 2010
Results First Posted Date  ICMJE April 19, 2011
Last Update Posted Date April 19, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
  • 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.
  • Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]
  • Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  • Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Percent of subjects who have at least a 2 point reduction at week 12 in the IGA score from baseline, and absolute change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ]
Change History Complete list of historical versions of study NCT00599521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to 12 weeks ]
Percent change in lesion count from baseline to week 12
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Percent change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Adapalene lotion 0.1%
    Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
  • Drug: Adapalene Lotion Vehicle
    Vehicle will be applied topically to the face, once a day, for 12 weeks
Study Arms  ICMJE
  • Experimental: Adapalene lotion 0.1%
    Intervention: Drug: Adapalene lotion 0.1%
  • Placebo Comparator: Adapalene Lotion vehicle
    Intervention: Drug: Adapalene Lotion Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2008)
1067
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)
1066
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599521
Other Study ID Numbers  ICMJE RD.06.SPR.18114
IND 076057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP