Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75%
 gel. This study is designed to evaluate the safety and efficacy of this formulation in
 subjects with Acne Vulgaris
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence
 study with clinical endpoint, at multiple study sites, designed to establish bioequivalence
 of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2%
 and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.

 The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and
 benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.
Inclusion Criteria:

 -  Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis
 of acne vulgaris

 -  On the face, ≥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). For the purposes of study treatment and evaluation, these lesions
 should be limited to the facial treatment area. Counts of nodules and cysts should be
 reported separately and not included in the inflammatory or non-inflammatory lesion
 counts. Lesions involving the eyes and scalp should be excluded from the count.
 (Subjects may have acne lesions on other areas of the body (e.g., on the back)).

 -  Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3,
 or 4.

 -  Willing to refrain from use of all other topical acne medications or antibiotics
 during the 12 week treatment period. Subjects may use other topical acne treatments
 that do not have significant or measurable systemic absorption for treatment of acne
 of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).

 -  Subjects who are 18 years of age or older must have provided Institutional Review
 Board (IRB) approved written informed consent. Subjects who are at least 12 years of
 age and less than 18 years of age 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 Health Insurance Portability and Accountability Act (HIPAA)
 authorization, if applicable.

 -  Male subjects and Female subjects of childbearing potential must use accepted methods
 of birth control or must agree to practice abstinence, from study start to 30 days
 after the last administration of study drug. All female subjects are considered to be
 of childbearing potential unless they have been surgically sterilized or have been
 postmenopausal for at least 1 year. Any of the following methods of birth control are
 acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®),
 vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier
 methods (e.g., condom and spermicide) or intrauterine device (IUD).

 -  Female subjects of child bearing potential must have a negative urine pregnancy test
 at baseline.

 -  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:

 -  History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any
 of the study medication ingredients or lincomycin or any other allowed product used
 during the study.

 -  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, acneform eruptions caused by medications, steroid acne, steroid
 folliculitis, or bacterial folliculitis).

 -  Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with
 diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive
 facial hair at least a day before visiting the site for study assessments.

 -  Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or
 therapeutic vitamin A supplements of greater than 10,000 units/day.

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

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

 -  Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3)
 systemic antibiotics, 4) systemic treatment for acne vulgaris or 5) systemic
 anti-inflammatory agents.

 -  Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3)
 topical acne treatments including over-the-counter preparations, 4) topical anti-
 inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.

 -  Subjects who have acne fulminans, and secondary acne (e.g., chloracne and drug induced
 acne) will be excluded from participation.

 -  Female subjects who are pregnant, nursing or planning to become pregnant during study
 participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from
 study participation.

 -  Subjects who have received radiation therapy and/or anti-neoplastic agents within 90
 days prior to baseline will be excluded from study participation.

 -  Subjects who have unstable medical disorders that are clinically significant or
 life-threatening diseases will be excluded from study participation.

 -  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 from study participation.

 -  Subjects who engage in activities that involve excessive or prolonged exposure to
 sunlight or weather extremes, such as wind or cold, will be excluded from study
 participation.

 -  Subjects who have facial sunburn will be excluded from study participation

 -  Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or
 use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged
 by their medical history will be excluded from study participation.

 -  History or presence of significant smoking (more than 10 cigarettes or any other form
 of tobacco smoking/day or consumption of tobacco products).

 -  Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood
 pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50
 beats/minute or more than 100 beats/minute.

 -  Subjects who have participated in an investigational drug study (i.e., subjects have
 been treated with an investigational drug) within 1 month 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.

 -  Major illness, as per investigator's discretion, during 3 months before screening.

 -  Subjects who have been previously enrolled in this study will be excluded from study
 participation.

 -  Subjects who have had laser therapy and electrodesiccation to the facial area within
 180 days prior to study entry will be excluded from participation.

 -  Subjects who have 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 will be excluded from participation.

 -  Subjects who have had general anesthesia for any reason and subjects who have received
 neuromuscular blocking agents within 14 days prior to study entry will be excluded
 from study participation.

 -  Subjects who have a baseline score of 3 (severe, marked/intense) as per the
 Application Site Reaction Scale (Section 5.2) will be excluded from participation.

 -  Any employees or staff of the research site are excluded from study participation.