Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | April 2011 |
A 4-Week, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Potential of Topically Applied 0.75% (w/w) MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum
production on the forehead of healthy male volunteers.
This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study
of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control.
Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo.
Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group.
One group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the
forehead for 28 consecutive days, and the other will receive placebo under the identical
regimen. Enrollment will be staggered to allow monitoring of safety and tolerability. A
lead cohort will include approximately 20 subjects (10 in the MTC896 Group and 10 in the
Placebo Group). Application on additional subjects will not be initiated until the lead
cohort has completed the study.
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