Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male V… (NCT01254162) | Clinical Trial Compass
CompletedPhase 2
Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
United States135 participantsStarted 2010-07
Plain-language summary
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.
Who can participate
Age range18 Years – 65 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Are healthy males;
* 2\. Are between 18 and 65 years of age;
* 3\. Have self-perceived oily skin confirmed by a clinical assessment;
* 4\. Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
* 5\. Have a negative urine drug screening test result;
* 6\. Have a negative HIV and hepatitis screening test result;
* 7\. Agree to use adequate contraceptive precautions (ie, use of condoms) during the conduct of the study;
* 8\. Have a body mass index (BMI) of 19 to 34 kg/m2;
* 9\. Are 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;
* 10\. Are willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the forehead during the study;
* 11\. Are willing to avoid sun exposure and to protect the forehead with a hat/visor;
* 12\. Are fluent in the English language;
* 13\. Complete a standard Medical Screening form as well as a Medical Personal History form; and
* 14\. Read, understand, and provide a signed informed consent.
Exclusion Criteria:
* 1\. Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
* 2\. Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
* 3\. Are not wil…
What they're measuring
1
A 20% reduction in sebum production as measured by the Sebumeter