BioPharmX has enrolled the first subject in a Phase llb clinical trial to evaluate BPX-04 for the treatment of rosacea.
The randomised, double-blind, vehicle-controlled trial intends to enrol 176 subjects who are at least 18 years old with an investigator’s global assessment (IGA) score of three or four, and 15 to 70 inflammatory lesions on their faces at baseline.
During the course of the 12-week, multi-centre, proof-of-concept (POC) trial, BPX-04 will be administered by BioPharmX’s HyantX delivery system.
The trial’s primary objective is an absolute mean change in the number of inflammatory lesions of rosacea from baseline to week 12.
Its secondary objective includes the proportion of subjects with at least a two-grade reduction in IGA to clear or almost clear from baseline to week 12.
In addition, the trial features the provision for an optional interim evaluation to adjust the study's sample size.
Therapeutics Clinical Research clinical dermatology director and the company's proof-of-concept trial principal investigator Neal Bhatia said: “Dermatologists and their patients are still searching for effective innovations in treatments for rosacea.
“The goal is to substantiate early research conclusions that suggest BPX-04 may offer the effective treatment of rosacea while minimising the unwanted adverse effects associated with oral forms of antibiotics.”
BPX-04 is a new topical gel formulation that contains 1% topical minocycline and is developed to treat rosacea.
Rosacea is a long-term skin condition that usually affects the face, and causes redness, pimples, swelling, and small and superficial dilated blood vessels.