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.
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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.
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.
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By GlobalDataAmerican 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.
