BioPharmX announced it has begun enrollment of patients in its phase 2b clinical trial measuring the efficacy and safety of BPX-10 for treating acne vulgaris.
The OPAL study is a 12-week multi-center, double-blind vehicle-controlled study of BPX-01, a fully solubilized topical minocycline gel that delivers the drug directly to the acne source while avoiding systemic exposure. Enrollment will include 225 people aged 9 to 40 years with moderate-to-severe inflammatory, non-nodular acne vulgaris, according to a press release.
Mean change from baseline in inflammatory lesion counts at week 12 will be the primary efficacy endpoint. Safety also will be assessed through multiple measurements.
“This trial is exciting for the dermatology community because the current standard of care for acne often exposes patients to systemic antibiotics,” Joely Kaufman, MD, a dermatologist at The Skin Research Institute in Miami and a researcher on the OPAL study, stated in the release. “BPX-01has the potential to significantly improve acne patients’ outcomes without common side effects in a way that no other acne medications have been able to do.”
Findings from a phase 2a study showed that BPX-01 eliminated more than 90% of acne-causing bacteria after four weeks, which was comparable to higher doses of oral minocycline, according to the release.
BioPharmX reports it expects result from the OPAL study in the first half of 2017.