Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo

Who cannot join

• 1. Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation. 2. Patients who have a known hypersensitivity to clindamycin phosphate or tretinoin or their excipients will be excluded from study participation. 3. Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema. 4. Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation. 5. Patients who have been treated with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded from study participation. 6. Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids,,α-hydroxy/glycolic acid, benzoyl peroxide, or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation. 7. Patients who have used erythromycin or erythromycin containing products in any form within 30 days prior to study entry (i.e., Visit 1) will be excluded from study participation. 8. Patients who are currently taking or have been treated with corticosteroids (including intranasal and inhaled corticosteroids) within 30 days prior to baseline will be excluded from study participation. 9. Patients who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 5). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills. 10. Patients who use androgen receptor blockers for acne (such as spironolactone or flutamide) will be excluded from study participation. 11. Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior to study entry,or have used therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 180 days prior to study entry, or have applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within the 30 days prior to baseline will be excluded from study participation. 12. Patients who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation. 13. Patients who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation. 14. Patients who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, patients who have any malignancy of the skin of the facial area will be excluded from study participation. 15. Patients who have facial hair will be excluded from study participation. Unacceptable facial hair includes, but is not limited to, beards, and long side-burns. A well-trimmed mustache is acceptable. Patients who have performed wax epilation of the face within 14 days prior to baseline will also be excluded from study participation. 16. Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation. 17. Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by history will be excluded from study participation. 18. Patients who have participated in an investigational drug study (i.e., patients have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion. 19. Patients who have been previously enrolled in this study will be excluded from study participation. 20. Patients who have had within 30 days prior to baseline or during the study cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy will be excluded from study participation. 21. Patients who have had laser therapy, and electrodesiccation to the facial area within 180 days prior to study entry will be excluded from participation. 22. Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation. 23. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation. 24. Patients who have a history of Crohn's disease, ulcerative colitis, regional enteritis, antibiotic-associated colitis will be excluded from study participation. 25. Patients who have a baseline local irritation score of 3 (severe, marked/intense) as scored using the Application Site Reaction Scale (Section 5.2) will be excluded from participation.