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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene

Criteria

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.