A Study to Determine the Efficacy of Topically Applied MTC896 Gel in Subjects With Acne Vulgaris

Exclusion Criteria

• •1. People who would otherwise qualify for the study, but are living in the same household as a study subject, are not allowed to participate in the study;
• •2. Pregnant or lactating or plan to become pregnant within 1 month (30 days) of study completion;
• •3. Known allergy/sensitivity to any of the study medication components;
• •4. Any skin condition which may interfere with the evaluation of safety or of acne vulgaris (e.g. rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne or folliculitis);
• •5. Excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris;
• •6. Excessive sun exposure, in the opinion of the Investigator, or use of tanning booths;
• •7. Active cystic acne or acne conglobata, acne fulminans, and secondary acne;
• •8. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator;
• •9. Participation in an investigational drug study within 30 days prior to Screening;
• •10. Is a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the Investigator;
• •11. Any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study;
• •12. Within 9 months (270 days) prior to Baseline and throughout the study:
• •\- Oral retinoid use (e.g. isotretinoin);
• •13. Within 6 months (180 days) prior to Baseline and throughout the study:
• •\- Treatment with Vitamin A supplements greater than 10,000 units/day;
• •14. Within 3 months (90 days) prior to Baseline and throughout the study:
• •* Use of androgen receptor blockers (such as spironolactone or flutamide);
• •* Initiation of treatment with hormonal therapy or dose change to hormonal therapy;
• •* Dose and frequency of use of any hormonal therapy started more than 3 months (90 days) prior to Baseline must remain unchanged throughout the study;
• •* Hormonal therapies include, but are not limited to, testosterone, anabolic steroids, birth control pills;
• •15. Within 8 weeks (56 days) prior to Baseline and throughout the study:
• •\- Facial procedures (chemical or laser peel, microdermabrasion, etc.);
• •16. Within 4 weeks (28 days) prior to Baseline and throughout the study:
• •* Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids);
• •* Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs; Note: Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis and if not used consecutively for \>14 days prior to Baseline is acceptable and does not require washout. Low dose (81 mg) aspirin taken daily is acceptable.
• •* Prescription topical retinoid use on the face (e.g. tretinoin, tazarotene, adapalene);
• •* Antifungals, antiretrovirals and antibiotics included in the CYP 3A4 and CYP 3A5;
• •17. Within 2 weeks (14 days) prior to Baseline and throughout the study:
• •* Treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide);
• •* Treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face;
• •18. Within 1 day prior to Baseline and throughout the study:
• •* Grapefruit juice which is included in the CYP 3A4 and CYP 3A5.