A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Condition: Acne Vulgaris; Acne
MeSH terms: Acne Vulgaris
Intervention: CT Gel; Clindamycin Gel (clindamycin ); Tretinoin Gel (tretinoin); Vehicle Gel
Intervention description: Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks; Clindamycin 1% gel applied topically once daily in the evening for 12 weeks; Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks; Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1649.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Acne

Summary:

      The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in
      subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel,
      Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 12 years of age or older in good general health

          -  Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

        Exclusion Criteria:

          -  Any nodulo-cystic lesions at Baseline

          -  Pregnancy or breast feeding

          -  History or presence of regional enteritis or inflammatory bowel disease or similar
             symptoms.

          -  Treatment with estrogens, including oral, implanted and topical contraceptives,
             androgens, or anti-androgenic agents for 12 weeks or less prior to study start.

          -  Use of topical anti-acne medications within the past 2 weeks.

          -  Use of topical or systemic antibiotics on the face within the past 2 weeks.

          -  Use of topical or systemic corticosteroids within the past 2 weeks.

          -  Use of systemic retinoids within the past 3 months.

          -  Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start
             of the study.

          -  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.

          -  Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD)
             vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and
             phenobarbital.

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2
             weeks or during the study.

          -  Concomitant use of tanning booths or sunbathing.

          -  Known hypersensitivity or previous allergic reaction to any of the active components,
             lincomycin, retinoids or excipients of the study product

          -  A significant medical history of or are currently immunocompromised

          -  Current drug or alcohol abuse. (Drug screening not required.)

          -  Use of any investigational therapy within 4 weeks of enrollment.

          -  Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study.