NCT01254162

Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Mimetica Pty Limited · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Oily Skin
• Seborrhea

Interventions

Type	Name	Description
DRUG	MTC896 Gel	0.75% w/w gel applied daily for 28 days to the forehead

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2010-12-06
• Last updated: 2014-09-12

Locations

1 site across 1 country: United States