A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

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