Clinical Phase I Study of OPB-2045, A New Antiseptic I. Skin Safety Assessment

• Published in: Skin research Vol. 41; no. 2; pp. 214 - 223
• Main Author: Sugai, Tetsuro
• Format: Journal Article
• Language: English
• Published: Meeting of Osaka Dermatological Association 1999
• Subjects: antiseptic; clinical phase I study; dermal safety; OPB-2045; patch-test
• ISSN: 0018-1390; 1884-541X
• DOI: 10.11340/skinresearch1959.41.214

The skin safety of OPB-2045 solution, a new monobiguanide antiseptic, was evaluated in singleblind open, 48-hour closed-patch, and photo-patch tests in 24 healthy adult male subjects. OPB-2045 solution was evaluated as safe in terms of urticarial response and photourticarial response, and negative in phototoxicity response. The skin irritation index was 6.3 for 0.05% OPB-2045 solution, 4.2 for 0.1% OPB-2045 solution, 20.8 for 0.2% OPB-2045 solution, 14.6 for 0.3% and 0.4% OPB-2045 solutions, and 22.9 for 0.5% OPB-2045 solution. Although the skin irritation of OPB-2045 solution tended to increase somewhat at concentrations of 0.2% and higher, the formulation was determined as safe at up to 0.5% when applied to intact skin and as acceptabl at up to 0.1% when applied to wounded or other types of non-healthy skin. There were no abnormal clinical symptoms or signs, or abnormal changes in clinical laboratory values (adverse drug reactions) for which a relationship to OPB-2045 could not be ruled out. The above results indicate, that OPB-2045 solution has low skin irritation and a high degree of safety and is a promising antiseptic for clinical use.