title: Topical rose bengal: pre-clinical evaluation of pharmacokinetics and safety.
abstract: OBJECTIVE
  Rose bengal (RB) is a potent photosensitizer that has largely been overlooked as a potential photodynamic therapy (PDT) agent. In this study, the feasibility of topical delivery of RB to the epidermis has been evaluated.
  
  
  METHODS
  Topical formulations of RB were assessed on murine and rabbit skin for pharmacokinetic properties, cutaneous toxicity, and photosensitization.
  
  
  RESULTS
  Hydrophilic formulations (<or=1% RB) exhibited rapid, selective, uniform delivery to the epidermis, with no significant acute cutaneous toxicity in normal skin. Illumination (532 nm) elicited no acute phototoxicity for light intensities <or=100 mW/cm(2) at a light dose of 100 J/cm(2); use of higher intensities resulted in superficial thermal damage. Repeat treatment of rabbit skin (weekly for four weeks) elicited minor phototoxicity only at the highest concentration (1% RB).
  
  
  CONCLUSIONS
  These results indicate that RB is safe for PDT treatment of skin disorders, exhibiting negligible effects in normal skin.
authors.affiliation: Provectus Pharmaceuticals, Inc., Knoxville, Tennessee 37931, USA. wachter@provectuscorp.com
authors.forename: Eric
authors.initials: E
authors.lastname: Wachter
authors.forename: Craig
authors.initials: C
authors.lastname: Dees
authors.forename: Jay
authors.initials: J
authors.lastname: Harkins
authors.forename: Timothy
authors.initials: T
authors.lastname: Scott
authors.forename: Mark
authors.initials: M
authors.lastname: Petersen
authors.forename: Rusty E
authors.initials: RE
authors.lastname: Rush
authors.forename: Amy
authors.initials: A
authors.lastname: Cada
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D017484:Dermatitis, Phototoxic / Q000209:etiology; D004307:Dose-Response Relationship, Radiation; D004353:Drug Evaluation, Preclinical; D005240:Feasibility Studies; D005260:Female; D005456:Fluorescent Dyes / Q000493:pharmacokinetics / Q000494:pharmacology*; D008297:Male; D051379:Mice; D008853:Microscopy; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000493:pharmacokinetics / Q000494:pharmacology*; D011817:Rabbits; D012395:Rose Bengal / Q000493:pharmacokinetics / Q000494:pharmacology*; D012867:Skin / Q000187:drug effects* / Q000528:radiation effects*
chemical_list: D005456:Fluorescent Dyes; D017319:Photosensitizing Agents; D012395:Rose Bengal