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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
0.75% w/w gel applied daily for 28 days to the forehead
TKL Research, Inc
Paramus, New Jersey, United States
A 20% reduction in sebum production as measured by the Sebumeter
Time frame: 28 days
Assess the safety and tolerability of the product when applied daily to the forehead for 28 days
Time frame: 28 days
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