Pharmacokinetic Study of MTC896 Gel in Subjects With Acne

Inclusion Criteria

• •1. Is a male or nonpregnant female who is at least 18 years of age at the time of screening;
• •2. Has provided written informed consent (which includes consent for photographs) to be taken at Baseline, EOT, and EOS visits;
• •3. Has a casual level (CL) of sebum ≥ 150 μg/cm2 on the forehead as measured with the Sebumeter®;
• •4. Has an SER of ≥ 150 μg/cm2/h on the forehead as measured with the Sebumeter®;
• •5. Has been diagnosed with inflammatory acne vulgaris of mild to moderate severity defined as:
• •* At least 20 inflammatory lesions,
• •* At least 20 noninflammatory lesions, and
• •* Investigator Global Assessment of 2 or greater;
• •6. Is willing to comply with the requirements of the protocol;
• •7. If female and of child-bearing potential, has a negative urine/serum pregnancy test at Screening and Baseline/Day 1 and is willing to use effective contraception during the study. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), diagnosed as infertile, have the same sex partner or a vasectomized male partner, are postmenopausal for at least 1 year, or are abstinent; (Acceptable methods of birth control are defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (eg, condom and spermicide) or an IUD. Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation);
• •8. If male, has been vasectomized or agrees to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application;
• •9. Is in good health and free from any disease which, in the opinion of the Investigator, would put the subject at risk if participating in the study;
• •10. Is free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events;
• •11. Is willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the face during the study;
• •12. Is willing to avoid sun exposure and to protect the face with a hat/visor;
• •13. If male, must agree to shave the treatment area and must agree not to alter his routine shaving regimen for the duration of the study;
• •14. Is willing to refrain from using any treatments, other than the study medication, including antibiotics, for acne present on the face. Topical acne treatments that do not have significant or measurable systemic absorption (eg, benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders, and chest only;