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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00598832
First received: January 11, 2008
Last updated: March 21, 2011
Last verified: March 2011

January 11, 2008
March 21, 2011
November 2007
October 2008   (final data collection date for primary outcome measure)
  • Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00598832 on ClinicalTrials.gov Archive Site
Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
Percent change in lesion count from baseline to week 12
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • 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
    Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
  • Experimental: Adapalene lotion 0.1%
    Intervention: Drug: Adapalene lotion 0.1%
  • Placebo Comparator: Adapalene Lotion vehicle
    Intervention: Drug: Adapalene Lotion Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1075
November 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00598832
RD.06.SPR.18113, IND 076057
No
Marie Ciardella Clinical Trials.gov Administrator, Galderma
Galderma
Not Provided
Not Provided
Galderma
March 2011

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