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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Topically applied once a day.
Lev Yasmin clinic
Netanya, Israel
Sourasky medical center
Tel Aviv, Israel
Tel-Nordau Clalit health services
Tel Aviv, Israel
Decrease in lesions count
The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Time frame: 12 weeks
Investigator global assessment
Physician's Global Improvement Assessment
Time frame: 12 weeks
% change in lesions count
The % change in lesions count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Time frame: 12 weeks
Global assessment of improvement by photographs
The photographs will assist in comparison of efficacy at subsequent visits compared to baseline
Time frame: 12 weeks
Subject-reported outcome assessment
Time frame: 12 weeks
Subjects safety
safety parameters will be assessed by * Physical examination * Vital signs (HR, BP, Body temperature) * Adverse events recording * Clinical assessment of skin irritation
Time frame: 12 weeks
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