Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Inclusion Criteria:

1. Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinicaldiagnosis of acne vulgaris

2. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e.,nodules and cysts)

3. Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4

4. Willing to refrain from use of all other topical acne medications or antibioticsduring the 12-week treatment period

5. If female of childbearing potential, willing to use an acceptable form of birthcontrol during the study

Exclusion Criteria:

1. Pregnant, breast feeding or planning a pregnancy

2. Presence of any skin condition that would interfere with the diagnosis or assessmentof acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cellcarcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroidfolliculitis, or bacterial folliculitis)

3. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interferewith diagnosis or assessment of acne vulgaris

4. History of hypersensitivity or allergy to adapalene, retinoids and/or any of the studymedication ingredients

5. Use within 6 months prior to baseline or during the study of oral retinoids (e.g.,Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)

6. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; useof such therapy must remain constant throughout the study

7. Use on the face within 1 month prior to baseline or during the study of 1) cryodestruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acnesurgery, 5) intralesional steroids, or 6) x-ray therapy

8. Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2)systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oralretinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents

9. Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2)topical retinoids, 3) topical acne treatments including over-the-counter preparations,

4. topical anti-inflammatory agents, or 5) topical antibiotics