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Proceedings Paper

Optical microscopy of targeted drug delivery and local distribution in skin of a topical minocycline: implications in translational research and guidance for therapeutic dose selection (Conference Presentation)
Author(s): Maiko Hermsmeier; Tanvee Sawant; Diana Lac; Akira Yamamoto; Xin Chen; Susan Y. Huang; Usha Nagavarapu; Conor L. Evans; Kin Foong Chan; AnnaMarie Daniels

Paper Abstract

Acne vulgaris is a chronic inflammatory skin condition commonly resulting in negative aesthetic and social impacts on those affected. Minocycline, currently available as an oral antibiotic for moderate to severe acne, has a known minimum inhibitory concentration (MIC) for the acne-causing bacterium Propionibacterium acnes (P. acnes) in vitro, with its anti-inflammatory properties also eliciting inhibitory effects on pro-inflammatory molecules. A novel topical gel composition containing solubilized minocycline (BPX-01) has been developed to directly deliver the drug to the skin. Because minocycline is a known fluorophore, fluorescence microscopy and concurrent quantitative measurements were performed on excised human facial skin dosed with different concentrations, in order to determine the spatial distribution of the drug and quantification of its local concentration in the epidermis and the pilosebaceous unit where P. acnes generally reside. Local minocycline delivery confirmed achievement of an adequate therapeutic dose to support clinical studies. Subsequently, a 4-week double-blind, randomized, vehicle controlled clinical study was performed to assess the safety and efficacy of 1% minocycline BPX-01 applied daily. No instances of cutaneous toxicity were reported, and a greater than 1 log reduction of P. acnes count was observed at week 4 with statistical significance from baseline and vehicle control. In addition, no detectable amounts of minocycline in the plasma were reported, suggesting the potential of this new formulation to diminish the known systemic adverse effects associated with oral minocycline. Follow-on clinical plans are underway to further establish the safety of BPX-01 and to evaluate its efficacy against inflammatory acne lesions in a 225 patient multi-center dose-finding study.

Paper Details

Date Published: 19 April 2017
PDF: 1 pages
Proc. SPIE 10037, Photonics in Dermatology and Plastic Surgery, 100370K (19 April 2017); doi: 10.1117/12.2256790
Show Author Affiliations
Maiko Hermsmeier, BioPharmX, Inc. (United States)
Tanvee Sawant, BioPharmX, Inc. (United States)
Diana Lac, BioPharmX, Inc. (United States)
Akira Yamamoto, BioPharmX, Inc. (United States)
Xin Chen, BioPharmX, Inc. (United States)
Susan Y. Huang, BioPharmX, Inc. (United States)
Usha Nagavarapu, BioPharmX, Inc. (United States)
Conor L. Evans, Wellman Ctr. for Photomedicine (United States)
Kin Foong Chan, BioPharmX, Inc. (United States)
AnnaMarie Daniels, BioPharmX, Inc. (United States)

Published in SPIE Proceedings Vol. 10037:
Photonics in Dermatology and Plastic Surgery
Bernard Choi; Haishan Zeng; Nikiforos Kollias, Editor(s)

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