Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Benzoyl peroxide gel; Clindamycin gel; Tazarotene cream; Vehicle gel; Vehicle cream
Intervention description: 5% benzoyl peroxide in a gel applied topically once a day; 1% clindamycin phosphate applied topically once a day; 0.1 % tazarotene in a cream applied topically once a day; Vehicle gel is an identical gel without the active ingredients; Vehicle cream is an identical cream without the active ingredients
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 591.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne; Acne Vulgaris; Pimples

Summary:

      Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
      for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
      combination product including these actives for the treatment of acne vulgaris.

      You may be suitable to take part in this study because you have acne vulgaris on your face.
      Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
      legs, and back.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.

          -  Subjects must have acne on their face.

          -  Female subjects of childbearing potential must have a negative pregnancy test. If
             sexually active, one medically acceptable forms of contraception must be practiced
             from baseline to the last study visit.

          -  Subjects must have the ability and willingness to follow all study procedures, attend
             all scheduled visits, and successfully complete the study.

          -  Subjects must be capable of understanding and willing to provide signed and dated
             written voluntary informed consent (and any local or national authorization
             requirements).

          -  Subjects must be able to complete the study and to comply with study instructions.

        Exclusion Criteria:

          -  Subjects who are pregnant, trying to become pregnant, or breast-feeding.

          -  Subjects with conditions that may influence the safety and or efficacy assessments of
             the study including, but not limited to: regional enteritis or inflammatory bowel
             disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis,
             or perioral dermatitis, subject who are immunocompromised or have had any major
             illness within 30 days before the screening examination

          -  History of known or suspected intolerance including any known hypersensitivity or
             previous allergic reaction to any of the ingredients of the study products

          -  Subjects who have used topical antibiotics or topical steroids on the face, facial
             procedures, or any investigational therapy within the past 4 weeks or systemic
             retinoids within the past 6 months.

          -  Subjects who have any other disease or condition, or are using any medication, that in
             the judgment of the investigator would put the subject at unacceptable risk for
             participation in the study.

          -  Other exclusion criteria may apply.