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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Adapalene lotion 0.1%
• Placebo Comparator: Adapalene Lotion vehicle

Primary Measures

• Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
  • Time Frame: From Baseline to Week 12
    Safety Issue?: No
• Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
  • Time Frame: Baseline to 12 weeks
    Safety Issue?: No
• Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

Secondary Measures

• Mean Percent Change in Total Lesion Count From Baseline to Week 12
  • Time Frame: From Baseline to 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Galderma Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599521

Study ID Number: RD.06.SPR.18114

ClinicalTrials.gov Identifier: NCT00599521

Health Authority: United States: Food and Drug Administration