NCT03257202

Topical Treatment and Prevalence of P. Acnes

Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.

Detailed description

P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Clindamycin 1% Gel	topical clindamycin
DRUG	Benzoyl peroxide 5% gel	topical benzoyl peroxide
DRUG	BenzaClin 5%-1% Topical Gel	Topical clindamycin and benzoyl peroxide together

Timeline

• Start date: 2017-09-11
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2017-08-22
• Last updated: 2019-11-13
• Results posted: 2019-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study