US-based pharmaceutical company BioPharmX has enrolled the first patient in its Phase IIb tOPicAL Minocycline Gel (OPAL) clinical trial of BPX-01 to treat acne vulgaris.
BPX-01 is a fully solubilised, non-oily, easy-to-use gel and a topical formulation of minocycline, a semisynthetic derivative of tetracycline.
It is delivered directly to the sebum-rich areas where P. acnes has occurred while avoiding systemic exposure.
The Phase IIb OPAL clinical trial has been designed as a multi-centre, double-blind, three-arm, vehicle controlled study to be conducted over a period of 12 weeks.
The trial is planning to include 225 people aged nine to 40 who suffer from moderate-to-severe inflammatory, non-nodular acne vulgaris.
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It is primarily focused on determining a baseline change in the inflammatory lesion counts at the 12th week, while the secondary goal is to achieve a two-grade reduction in Investigator Global Assessment (IGA) after the 12th week compared to baseline.
American Academy of Dermatology fellow Miami Skin Research Institute board certified dermatologist and OPAL study principal investigator Joely Kaufman said: "This trial is exciting for the dermatology community because the current standard of care for acne often exposes patients to systemic antibiotics.
"BPX-01 has 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."
The result of the OPAL study is slated to be released next year.
