A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

Exclusion Criteria

• •1. Patients who had been treated with:
• •* systemic retinoids during a 6-month period before Visit 1 or by systemic antibiotics during a 4-week period before Visit 1
• •* or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid, dapsone) or systemic corticosteroids during a 2-week period before the first dose of study medication.
• •2. History of hereditary angio-edema
• •3. Pregnancy, lactation or patient, who is not practicing effective contraception.
• •4. Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
• •5. A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
• •6. Erythroderma, immunodeficiency disorders and Mycosis Fungoides
• •7. History of Epilepsy or Parkinson's disease
• •8. History of alcohol and/or drug abuse within 5 years of screening
• •9. Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
• •10. Any single facial skin condition assessment graded as "Severe" at Visit 1
• •11. Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
• •12. Refusal to cease using the following types of facial products: astringents, toners, abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids .
• •13. Using medications that are reported to exacerbate acne .
• •14. Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, during the 4 weeks prior to Visit 1.
• •15. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).
• •16. Patients using comedogenic makeup.
• •17. Have a known hypersensitivity or previous allergic reaction to any of the components .
• •18. Employees of the clinical research site or organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
• •19. Have a member of the same household in this trial.
• •20. Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• •21. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
• •22. Patients who withdraw consent before completion of Visit 1 procedures