Foamix Pharmaceuticals has completed patient enrolment and dosing in the FX2016-11 and FX2016-12 studies designed to treat moderate-to-severe papulopustular rosacea.
Both trials are Phase lll clinical studies investigating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for rosacea.
The identical, multi-centre, double-blinded, vehicle-controlled studies are being conducted simultaneously, with plans to provide top-line results by the fourth quarter of this year.
The FX2016-11 trial enrolled a total of 751 patients, while the FX2016-12 included 771 patients.
As part of the trials, the enrolled patients were randomised on a 2:1 basis to provide FMX103 and a study vehicle once daily for 12 weeks.
The primary efficacy endpoints of the trial are the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment and the mean change from baseline in inflammatory lesion counts in each treatment group at week 12.
Safety evaluations of the trials comprise reported adverse events, evaluation of dermal tolerability, as well as clinical laboratory tests and vital signs.
Foamix aims to release long-term safety data from both trials by the first half of next year.
In addition, the company has enrolled 505 patients in the FX2016-13 trial, a long-term open-label safety extension study that seeks to evaluate the safety of intermittent use of FMX103 for up to an additional nine months.
Patients of this trial took part in either of the FX2016-11 and FX2016-12 studies.
FMX103 is a minocycline foam developed for the treatment of rosacea, a chronic skin disease causing inflammatory lesions on the nose, cheeks, chin and forehead.