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 diagnosis
of acne vulgaris.

- Subjects who are 18 years of age or older (up to the age of 40 inclusive) must have
provided IRB approved written informed consent. Subjects ages 12 to 17 years of age
inclusive must have provided IRB approved written assent; this written assent must be
accompanied by an IRB approved written informed consent from the Subject's legally
acceptable representative (i.e., parent or guardian). In addition, all Subjects or
their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA
authorization.

- Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed
comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2
nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the
purposes of study treatment and evaluation, these lesions should be limited to the
facial treatment area. When counting facial acne lesions, it is important that all
lesions 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 on
other areas of the body which will also be excluded from the count, treatment, and the
Investigator'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 or
antibiotics during the 12-week treatment period for acne vulgaris, other than the
Investigational Product.

- Female Subjects of childbearing potential (excluding women who are surgically
sterilized or postmenopausal for at least 1 year), in addition to having a negative
urine pregnancy test, must be willing to use an acceptable form of birth control from
the day of the first dose administration to 30 days after the last administration of
study drug. For the purpose of this study the following are considered acceptable
methods 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 the
study, a 2nd acceptable method of birth control should be documented. A sterile sexual
partner is NOT considered an adequate form of birth control. Hormonal contraceptives
should not be initiated or changed during the study.

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

- Subjects must be willing and able to understand and comply with the requirements of
the 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 of
acne vulgaris. Such conditions include, but are not limited to the following: auto
immune disease, rosacea; seborrheic dermatitis; perioral dermatitis;
corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions
caused 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 minimum
period of 14 days prior to study entry and must agree to not change make-up brand/type
or frequency of use throughout the study.

Exclusion Criteria:

- Female Subjects who are pregnant, nursing or planning to become pregnant during study
participation.

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

- Subjects with the presence of any skin condition that would interfere with the
diagnosis 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.) that
would interfere with diagnosis or assessment of acne vulgaris.

- Subjects who have performed wax depilation of the face within 14 days prior to
baseline.

- Subjects who have used within 6 months prior to baseline or use during the study of
oral 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 prior
to 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 month
prior 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 to
baseline 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 to
baseline 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-counter
preparations

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 90
days prior to baseline.

- Subjects who have unstable medical disorders that are clinically significant or
life-threatening diseases.

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

- Subjects who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.

- Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or
use drugs of abuse (including, but not limited to cannabinoids, cocaine and
barbiturates).

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

- 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 and
safety 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.