Evaluation of the antiseptic efficacy and local tolerability of a polihexanide-based antiseptic on resident skin flora.

ABSTRACT

OBJECTIVE: The primary objective of this study was to compare the antimicrobial efficacy of polihexanide 0.02% and 0.04% with chlorhexidine 0.05% after 30 minutes of topical treatment on healthy intact skin. DESIGN: This study was performed as a double-blind, randomized, comparator-controlled, 3-arm, crossover study. SETTING: A phase I dermatological study unit. PARTICIPANTS: Twenty healthy volunteers with intact skin. INTERVENTIONS: Test areas of 5 cm on the subjects' arms were treated with the investigational products using a polyurethane swab. Skin swabs were taken before and after treatment for quantitative microbial evaluation. MAIN OUTCOME MEASURES: The main outcome measure was the log reduction factor of colony-forming units on the skin after 30 minutes of treatment. MAIN RESULTS: No statistically significant difference was seen between both of the polihexanide test products (mean lgRF polihexanide 0.02%, 1.2251 [SD, 0.9399]; mean lgRF polihexanide 0.04%, 1.8991 [SD, 0.88]) and the comparator, chlorhexidine 0.05% (P > .1). CONCLUSION: The results of this study indicate that polihexanide is a suitable alternative to chlorhexidine for skin and wound antisepsis.