To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel; DUAC® Gel; Placebo
Intervention description: Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 850.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; DUAC; CADILA; CLIANTHA

Summary:

      This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo
      Controlled, Three Arm Clinical Study.

      The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate
      1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of
      Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo
      respectively.

      Total study duration will be for a period of 78 days which includes treatment duration of 77
      days.

      850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria
      mentioned in the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis
             of Acne vulgaris

          2. 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).

          3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4

          4. Willing to refrain from use of all other topical acne medications or antibiotics
             during the 11 week treatment period.

          5. If female of childbearing potential, willing to use an acceptable form of birth
             control during the study.

          6. Have used the same brand of make-up for a minimum period of 2 weeks prior to
             randomization, for subjects who use make-up, and agree to not change make-up brands or
             types during the study.

          7. Willing to provide written informed consent or assent (HIPAA consent/authorization, as
             applicable)

        Exclusion Criteria:

          1. 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).

          2. Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne
             and drug induced acne).

          3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
             with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.

          4. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any
             of the study medication ingredients.

          5. Patients who have a severe or intense irritation on the Face.

          6. Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g.
             Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day
             (multivitamins are allowed).

          7. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral
             contraceptives; use of such therapy is allowed if it will remain constant throughout
             the study.

          8. Use on the face within 1 month prior to baseline (Randomization) 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.

          9. Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2)
             systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris
             (other than oral retinoids, which require a 6-month washout), or 5) systemic
             anti-inflammatory agents.

         10. Use within 2 weeks prior to baseline (Randomization) 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.

         11. Patients who have had general anesthesia for any reason and patients who have received
             neuromuscular blocking agents within 14 days prior to study entry (Randomization).

         12. Concomitant use of facial product containing glycolic or other acids, masks, washes or
             soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or
             moisturizers containing retinol, salicylic or α- or β-hydroxy acids.

         13. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12),
             haloperidol, halogens such as iodide and bromide, lithium, hydantoin and
             phenobarbital.

         14. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2
             weeks or during the study.

         15. Concomitant use of tanning booths or sunbathing.

         16. A significant medical history of or are currently immunocompromised

         17. Have any systemic or dermatologic disease that may affect the evaluation of study
             results.

         18. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or
             antibiotic-associated colitis.

         19. Subjects with clinically significant unstable medical disorders, life-threatening
             disease, or current malignancies.

         20. Subjects who engage in activities that involve excessive or prolonged exposure to
             sunlight.

         21. Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to
             Randomization.

         22. Female subjects who are breast-feeding or planning to become pregnant.

         23. Subjects who have been treated with an investigational drug or investigational device
             within a period of 30 days prior to study enrollment.