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OpenTrials
Completed

NCT Number: NCT03257202

Topical Treatment and Prevalence of P. Acnes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteer
  • age > 18

Exclusion criteria

  • history of antibiotic use in the last month
  • active acne on the back
  • non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)

Treatment and study plan

Clindamycin 1% Gel

Drug

topical clindamycin

Benzoyl peroxide 5% gel

Drug

topical benzoyl peroxide

BenzaClin 5%-1% Topical Gel

Drug

Topical clindamycin and benzoyl peroxide together

Primary outcomes

  1. Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms

    Time frame: 21 days

    Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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