Overview

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.