Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Onexton; Clindamycin/benzoyl peroxide gel; Placebo
Intervention description: Topical gel for treating acne; Generic Clindamycin/benzoyl peroxide gel for treating acne; Vehicle gel used as a placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 862.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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
    

Eligibility criteria:

        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.