NCT01362010

Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients

Pilot, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Acne Vulgaris Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.

Detailed description

This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris. The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Topical Minocycline Foam FXFM244	Topically applied once a day.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2011-05-27
• Last updated: 2013-08-15

Locations

3 sites across 1 country: Israel