Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: clindamycin / benzoyl peroxide gel; clindamycin gel; BPO gel; vehicle gel
Intervention description: Once a day application to the face; Once a day application to the face; Once a day application to the face; Once a day application to the face
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: 1315.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Acne

Summary:

      This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a
      clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 12 to 45 years of age, inclusive, and in good general health.

          -  Clinical diagnosis of acne vulgaris

          -  Females of childbearing potential participating in the study must agree to use a
             medically acceptable method of contraception while receiving protocol-assigned
             product.

          -  Have the ability and willingness to follow all study procedures, attend all scheduled
             visits, and successfully complete the study.

          -  Have the ability to understand and sign a written informed consent form, which must be
             completed prior to study specific tasks being performed. Subjects under the legal age
             of consent in the state/province/country where the study is conducted must provide
             assent and have the written informed consent of a parent or guardian.

        Exclusion Criteria:

          -  Are pregnant or breast-feeding.

          -  Have a history or presence of other conditions that may increase the risk of the
             subject participating in the study and/or affect the evaluated outcomes.

          -  Used topical antibiotics on the face or used systemic antibiotics within the past 2
             weeks.

          -  Used topical corticosteroids on the face or systemic corticosteroids within the past 4
             weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for
             facial acne is acceptable.

          -  Used systemic retinoids within the past 6 months or topical retinoids within the past
             6 weeks.

          -  Received treatment with estrogens (including oral, implanted, injected and topical
             contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately
             prior to starting study product. Subjects who have been treated with estrogens, as
             described above, androgens, or anti-androgenic agents for more than 12 consecutive
             weeks prior to start of study product are allowed to enroll as long as they do not
             expect to change dose, drug, or discontinue use during the study.

          -  Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates,
             etc.) within the past 2 weeks.

          -  Used abradents or facial procedures, within the past 2 weeks.

          -  Use medications that may exacerbate acne.

          -  Have a known hypersensitivity or have had previous allergic reaction to any of the
             active components, lincomycin, or excipients of the study product.

          -  Used any investigational therapy within the past 4 weeks, or currently participating
             in another clinical study.