Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

Inclusion Criteria:

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosisof acne vulgaris.

• Subjects who are 18 years of age or older (up to the age of 40 inclusive) must haveprovided IRB approved written informed consent. Subjects ages 12 to 17 years of ageinclusive must have provided IRB approved written assent; this written assent must beaccompanied by an IRB approved written informed consent from the Subject's legallyacceptable representative (i.e., parent or guardian). In addition, all Subjects ortheir legally acceptable representatives (i.e., parent or guardian) must sign a HIPAAauthorization.

• Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closedcomedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For thepurposes of study treatment and evaluation, these lesions should be limited to thefacial treatment area. When counting facial acne lesions, it is important that alllesions be counted, including those present on the nose. Lesions involving the eyes,lip and scalp should be excluded from the count. Subjects may have acne lesions onother areas of the body which will also be excluded from the count, treatment, and theInvestigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).

• Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

• Subjects must be willing to refrain from using all other topical acne medications orantibiotics during the 12-week treatment period for acne vulgaris, other than theInvestigational Product.

• Female Subjects of childbearing potential (excluding women who are surgicallysterilized or postmenopausal for at least 1 year), in addition to having a negativeurine pregnancy test, must be willing to use an acceptable form of birth control fromthe day of the first dose administration to 30 days after the last administration ofstudy drug. For the purpose of this study the following are considered acceptablemethods of birth control: oral or injectable contraceptives, contraceptive patches,Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive);Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide);IUD, or abstinence. If a subject who was abstinent becomes sexually active during thestudy, a 2nd acceptable method of birth control should be documented. A sterile sexualpartner is NOT considered an adequate form of birth control. Hormonal contraceptivesshould not be initiated or changed during the study.

• All male Subjects must agree to use accepted methods of birth control with theirpartners, from the day of the first dose administration to 30 days after the lastadministration of study drug. Abstinence is an acceptable method of birth control.Female partners should use an acceptable method of birth control as described in theabove Item Number 6.

• Subjects must be willing and able to understand and comply with the requirements ofthe protocol, including attendance at the required study visits.

• Subjects must be in good health and free from any clinically significant disease,including but not limited to, conditions that may interfere with the evaluation ofacne vulgaris. Such conditions include, but are not limited to the following: autoimmune disease, rosacea; seborrheic dermatitis; perioral dermatitis;corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptionscaused by make-up, medication, facial psoriasis and facial eczema.

• Subjects who use make-up must have used the same brands/types of make-up for a minimumperiod of 14 days prior to study entry and must agree to not change make-up brand/typeor frequency of use throughout the study.

Exclusion Criteria:

• Female Subjects who are pregnant, nursing or planning to become pregnant during studyparticipation.

• Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/orany of the study medication ingredients, have a known hypersensitivity to adapaleneand its excipients.

• Subjects with the presence of any skin condition that would interfere with thediagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis,psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).

• Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) thatwould interfere with diagnosis or assessment of acne vulgaris.

• Subjects who have performed wax depilation of the face within 14 days prior tobaseline.

• Subjects who have used within 6 months prior to baseline or use during the study oforal retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).

• Subjects who have used estrogens or oral contraceptives for less than 3 months priorto baseline; use of such therapy must remain constant throughout the study.

• Subjects who have used any of the following procedures on the face within 1 monthprior to baseline or during the study :

1. cryodestruction or chemodestruction,

2. dermabrasion,

3. photodynamic therapy,

4. acne surgery,

5. intralesional steroids, or

6. X-ray therapy.

• Subjects who have used any of the following treatments within 1 month prior tobaseline or during the study:

1. systemic steroids,

2. systemic antibiotics,

3. systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or

4. systemic anti-inflammatory agents.

• Subjects who have used any of the following treatments within 2 weeks prior tobaseline or during the study:

1. topical steroids,

2. topical retinoids,

3. α-hydroxy/glycolic acid,

4. benzoyl peroxide, or any other topical acne treatments including over-the-counterpreparations

5. topical anti-inflammatory agents, or

6. topical antibiotics.

• Use of spironolactone within 1 month before Screening/Baseline.

• Subjects who have received radiation therapy and/or anti-neoplastic agents within 90days prior to baseline.

• Subjects who have unstable medical disorders that are clinically significant orlife-threatening diseases.

• Subjects who have on-going malignancies requiring systemic treatment will be excludedfrom study participation. In addition, Subjects who have any malignancy of the skin ofthe facial area will be excluded.

• Subjects who engage in activities that involve excessive or prolonged exposure tosunlight or weather extremes, such as wind or cold.

• Subjects who consume excessive amounts of alcohol (greater than two drinks per day) oruse drugs of abuse (including, but not limited to cannabinoids, cocaine andbarbiturates).

• Subjects who have participated in an investigational drug study (i.e., Subjects havebeen treated with an Investigational Drug) within 30 days prior to baseline will beexcluded from study participation. Subjects who are participating in non-treatmentstudies such as observational studies or registry studies can be considered forinclusion.

• Subjects who have been previously enrolled in this study.

• Subjects who had laser therapy, electrodessication and phototherapy (e.g.,ClearLight®) to the facial area within 1 month prior to study entry.

• Subjects who had cosmetic procedures (e.g., facials) which may affect the efficacy andsafety profile of the Investigational Product within 14 days prior to study entry.Cosmetic procedures and facials are prohibited throughout the study

• Subjects who currently have or have recently had bacterial folliculitis on the face.

• Subjects with a baseline irritation score of 3 (severe, marked/intense) for erythema,dryness, burning/stinging, erosion, edema, pain and itching will not be enrolled.