Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.

Exclusion Criteria

• •1. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
• •2. Use of androgen receptor blockers (such as spironolactone or flutamide);
• •3. Severe cystic acne, acne conglobate, acne fulminans, or secondary acne;
• •4. Use of phototherapy devices, energy-based devices, adhesive cleansing strips, or cosmetic procedures (e.g., facials, peeling, comedo extraction) in the past week;
• •5. Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study;
• •6. Prior or current concomitant therapies that would interfere with assessments in the study;
• •7. Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
• •8. Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[e.g., benzamycin\]), retinoids; other topical acne treatments (e.g., photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks;
• •9. Oral retinoid use (e.g., isotretinoin) within 6 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline;
• •10. Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;
• •11. Use of medicated make-up (including anti-aging make-up) throughout the study;
• •12. Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3) antibiotics known to impact acne, 4) immunosuppressive agents, or immunomodulators;
• •13. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical acne treatments or 4) topical antibiotics;
• •14. Use of medicated cleansers on the face (throughout the study);
• •15. Use of topical astringents or abrasives, medical topical preparations (prescription and OTC products) within 2 days prior to Baseline and throughout the study;
• •16. Systemic or skin infection requiring antimicrobial therapy;
• •17. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;
• •18. Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome;
• •19. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator;
• •20. Active drug or alcohol dependence;
• •21. Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study;
• •22. Previous clinical trial participation for the indication being treated in this protocol.