A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%; Acanya Gel; Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
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: Double (Participant, Investigator)
Enrollment: 1180.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the efficacy and safety of Perrigo's test
      formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to
      the already marketed formulation, Acanya gel in patients with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject and/or parent or legally authorized representative must sign an Institutional
             Review Board (IRB) approved written informed consent/assent.

          2. Male or female, 12 to 40 years of age, inclusive.

          3. Definite clinical diagnosis of facial acne vulgaris with an inflammatory lesion
             (papules and pustules) count between 20 and 50 and a non-inflammatory (open and closed
             comedones) lesion count between 25 and 100 and no more than 2 nodulocystic lesions
             (i.e., nodules and cysts) including those present on the nose.

          4. Baseline Investigator's Global Assessment Score of 3 (moderate severity) or 4 (severe)
             on a severity scale of 0 to 4.

          5. Willing and able to understand and comply with the requirements of the study, apply
             the medication as instructed, refrain from use of all other topical acne medication or
             topical antibiotics during the 12-week treatment period, return for the required
             treatment period visits, comply with therapy prohibitions, and are able to complete
             the study.

          6. In general good health and free from any clinically significant disease, other than
             acne vulgaris, that might interfere with the study evaluations.

          7. Females of childbearing potential (excluding women who are surgically sterilized or
             post menopausal for at least 2 years), in addition to having a negative urine
             pregnancy test, must be willing to use an acceptable form of birth control during the
             study. For the purpose of this study, the following are considered acceptable methods
             of birth control: Oral Contraceptives, Contraceptive patches, Contraceptive Injection
             (Depo-Provera), Contraceptive Implant (Implanon), Vaginal Contraceptive (Nuva-Ring),
             IUD, hormonal IUD (Mirena); double-barrier methods (e.g. condom and spermicide) and
             abstinence with a documented second acceptable method of birth control should subject
             become sexually active. A sterile sexual partner is not considered an adequate form of
             birth control. Subjects entering the trial that are on hormonal contraceptives must
             have been on this method for at least 3 months (90 days) prior to the trial and
             continue the method for the duration of the trial. Subjects who had used hormonal
             contraception and stopped must have stopped no less than 3 months (90 days) prior to
             baseline.

        Exclusion Criteria:

          1. Pregnant, breast feeding, or planning a pregnancy within the study participation
             period.

          2. More than 2 facial nodulocystic lesions (i.e. nodules and cysts).

          3. Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne,
             etc.).

          4. Active cystic acne or Polycystic Ovarian Syndrome.

          5. History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or
             antibiotic-associated colitis.

          6. Use of neuromuscular blocking agents (nondepolarizing agents and depolarizing agents)

          7. Any other facial skin condition that might interfere with acne vulgaris diagnosis
             and/or assessment (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell
             carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid
             folliculitis, or bacterial folliculitis).

          8. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
             with diagnosis or assessment of acne vulgaris.

          9. History of unresponsiveness to topical Clindamycin Phosphate and/or benzoyl peroxide
             therapy.

         10. Use of systemic Clindamycin products 4 weeks prior to baseline or throughout the
             study.

         11. History of hypersensitivity or allergy to Clindamycin Phosphate, benzoyl peroxide
             and/or any ingredient in the study medication.

         12. 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).

         13. Use within 30 days prior to baseline or during the study of therapeutic vitamin D
             supplement (daily multivitamins with total 800IU Vitamin D are allowed).

         14. Use of medications known to exacerbate acne (Vitamin B12, lithium, corticosteroids;
             Vitamin B12, etc as part of a multivitamin regimen is allowed).

         15. Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives
             and androgens) 3 months prior to base-line or throughout the study. Use of such
             therapy must remain constant during the study.

         16. Use of medicated make-up throughout the study and significant change in the use of
             consumer products within 30 days of study entry and throughout the study (other than
             study supplied cleanser and lotion).

         17. Use within 30 days prior to baseline or during the study of 1) systemic steroids*, 2)
             systemic (e.g., oral or injectable) antibiotics, 3) systemic treatment for acne
             vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic
             anti-inflammatory or immunosuppressive agents**. (*Intranasal and inhaled
             corticosteroids do not require a washout and may be used throughout the study if at a
             stable and standard dose.)**Subjects may use Acetaminophen for pain relief, as needed
             throughout the study).

         18. Use within 14 days prior to baseline or during the study of 1) topical steroids, 2)
             topical retinoids, 3) topical anti-acne medications (e.g. Benzoyl peroxide, retinoids,
             azelaic acid, α-hydroxy/glycolic acid, Clindamycin, etc.) including OTC preparations
             4) benzoyl peroxide, 5) topical anti-inflammatory agents, or 6) topical antibiotics.

         19. Use on the face within 30 days prior to baseline or during the study of 1)
             cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne
             surgery, 5) intralesional steroids, or 6) x-ray therapy.

         20. Use of medicated cleansers (e.g. benzoyl peroxide, salicylic acid, sulfur or
             triclosan) within 2 weeks of study start and throughout the study.

         21. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements.

         22. Use of Spironolactone for 4 weeks prior to baseline visit and throughout the study
             period is prohibited.

         23. Use of Antipruritics, including antihistamines within 24 hours of all study visits
             (Visit 1 through Visit 4).

         24. Participation in any clinical study involving an investigational product or device in
             the 4 weeks prior to study entry or throughout the study.

         25. Previous enrollment in this current study.

         26. Use of tanning booths, sun lamps, sunbathing or excessive exposure to the sun 1 week
             prior to enrollment and throughout the study.