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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

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
  • Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
• Drug: Vehicle
  • Vehicle will be applied topically to the face, once a day, for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    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 Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Overall Contact: Kathleen Smith 707-793-2600 ksmith@dowpharmsci.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00598832

Study ID Number: RD.06.SPR.18113

ClinicalTrials.gov Identifier: NCT00598832

Health Authority: United States: Food and Drug Administration