A Novel Combination Oral Agent to Treat Acne Vulgaris

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS

The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females

Inclusion Criteria:

• Healthy females 13 years of age or older
• Non-pregnant, non-lactating females
• Signed written informed consent form
• Must be able to understand and be willing to follow all study instructions
• Have a clinical diagnosis of acne vulgaris

Exclusion Criteria:

• Female subjects who are pregnant or nursing
• Any concomitant dermatologic condition that may affect outcome measures
• Concurrent use of any other medication to treat acne vulgaris
• Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
• Are currently using any other investigational agent or device
• Have participated in any other clinical study within 90 days prior to enrollment
• Employees or family members of sponsor or research site