A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tazarotene foam; Vehicle Foam
Intervention description: Tazarotene foam once a day application to the face; Vehicle Foam once a day application to the face
Intervention MeSH terms: Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 744.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Ance

Summary:

      The purpose of this study is to assess safety and efficacy of a new foam formulation of
      tazarotene in subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 12 through 45 years, inclusive, who is in good general health.

          -  An ISGA score of 3 or greater at baseline.

          -  Lesion counts meeting both of the following criteria:

               1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular
                  lesion (<5mm), with NO cystic lesions.

               2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.

          -  Regular menstrual cycle prior to study entry for females of childbearing potential.

          -  Negative urine pregnancy test for females of childbearing potential. • Sexually active
             females of childbearing potential participating in the study must agree to use a
             medically acceptable method of contraception while receiving protocol-assigned
             product. A woman of childbearing potential is defined as one who is biologically
             capable of becoming pregnant; including perimenopausal women who are less than 2 years
             from their last menses.

        Women who are not currently sexually active must agree to use medically accepted method of
        contraception should they become sexually active while participating in the study. Male
        subjects and/or their partners must use a medically acceptable form of contraception.

          -  Capable of understanding and willing to provide signed and dated written voluntary
             informed consent before any protocol specific procedures are performed.

          -  Ability and willingness to follow all study procedures, attend all scheduled visits,
             and successfully complete the study.

        Exclusion Criteria:

          -  Female who is pregnant, trying to become pregnant, or breast feeding.

          -  Use of topical antibiotics on the face within the past 2 weeks.

          -  Use of systemic antibiotics for acne treatment within the past 4 weeks.

          -  Concurrent use of medications known to be photosensitizers (eg, thiazides,
             tetracyclines) because of the possibility of augmented photosensitivity.

          -  Use of topical corticosteroids on the face within the past 2 weeks or systemic
             corticosteroids within the past 4 weeks.

          -  Use of systemic retinoids (eg, isotretinoin) within the past 6 months.

          -  Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less
             immediately prior to study enrollment. Subjects that have been treated with these
             medications for more than 12 consecutive weeks prior to study enrollment are allowed
             to enroll as long as they do not expect to change the dose or drug, or to discontinue
             use during the study and it has not been indicated for the treatment of acne vulgaris.

          -  Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates)
             within the past 2 weeks.

          -  Concomitant use of facial products such as: abradants, facials, peels containing
             glycolic or other acids, masks, washes or soaps.

          -  Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of
             certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these
             may impact efficacy assessments. Multivitamins, iron supplements, and folate are
             acceptable.

          -  Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within
             the past 4 weeks.

          -  Require or desire excessive or prolonged exposure to ultraviolet light during the
             study.

          -  Known hypersensitivity or previous allergic reaction to any of the active components
             of the study product.

          -  A significant medical history of or currently immunocompromised.

          -  Use of any investigational product within the past 4 weeks or currently participating
             in another clinical study.

          -  Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study.

          -  Any major illness within 30 days before study enrollment.

          -  Currently lives in the same household as currently enrolled subjects; is an employee
             of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family
             member (eg, partner, offspring, parents) of an employee involved in the study