Clinical investigation of topical antimicrobials in healthy volunteers

Ann Pharmacother. 1997 Jan;31(1):34-8. doi: 10.1177/106002809703100104.

Abstract

Objective: To evaluate the antibacterial activity, onset of action, and duration of action of four topical antimicrobial gels containing cetrimide, bacitracin, polymyxin B sulfate, and a placebo gel.

Design: Multiples (1 x, 2x, 4x, 8x) of minimally inhibitory in vitro drug concentrations were formulated in a gel vehicle. Antibacterial activity was evaluated using a scrub-wash methodology on artificially inoculated skin over an 8-hour study period.

Setting and participants: Healthy volunteers with intact forearm skin participated in the study. A standardized culture of Staphylococcus aureus NCTC 6571 was applied to four areas on each forearm, randomly assigned topical treatments were applied, and sites were sampled at predetermined time intervals using a surfactant wash fluid.

Outcome measures: Recovered bacteria were quantitated, allowing a comparison of antibacterial activity.

Results: Two-way and one-way ANOVA and a Scheffe test confirmed significant differences in antibacterial effect between the formulations containing 4 and 8 times the minimally inhibitory in vitro concentrations and placebo (p < 0.05). Duration of action was similar for all preparations; however, onset appeared to be faster with the formulations containing 4 and 8 times minimally inhibitory in vitro concentrations.

Conclusions: The two topical preparations containing 4 and 8 times the minimally inhibitory in vitro concentrations of cetrimide, bacitracin, and polymyxin B sulfate demonstrated significant antibacterial activity and may have potential for further clinical investigations.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / pharmacology*
  • Anti-Infective Agents, Local / administration & dosage
  • Anti-Infective Agents, Local / pharmacology*
  • Bacitracin / administration & dosage
  • Bacitracin / pharmacology*
  • Cetrimonium
  • Cetrimonium Compounds / administration & dosage
  • Cetrimonium Compounds / pharmacology*
  • Female
  • Gels
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Polymyxin B / administration & dosage
  • Polymyxin B / pharmacology*
  • Random Allocation
  • Skin / drug effects
  • Staphylococcus aureus / drug effects*

Substances

  • Anti-Bacterial Agents
  • Anti-Infective Agents, Local
  • Cetrimonium Compounds
  • Gels
  • Bacitracin
  • Polymyxin B
  • Cetrimonium