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Topical Treatment and Prevalence of P. Acnes

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ClinicalTrials.gov Identifier: NCT03257202
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
George F. Hatch, University of Southern California

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 22, 2017
Results First Submitted Date  ICMJE June 20, 2019
Results First Posted Date  ICMJE November 13, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE September 11, 2017
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
positive growth [ Time Frame: 21 days ]
detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
positive hemolysis [ Time Frame: 21 days ]
detected presence of hemolysis on brucella agar (% hemolysis)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Treatment and Prevalence of P. Acnes
Official Title  ICMJE Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Healthy volunteers
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • No Intervention: Control
    No topical treatment
  • Experimental: Clindamycin alone
    topical clindamycin alone using Clindamycin 1% Gel
    Intervention: Drug: Clindamycin 1% Gel
  • Experimental: Benzoyl peroxide alone
    topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
    Intervention: Drug: Benzoyl peroxide 5% gel
  • Experimental: Clindamycin and benzoyl peroxide
    Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel
    Intervention: Drug: BenzaClin 5%-1% Topical Gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2017)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03257202
Other Study ID Numbers  ICMJE HS-17-00319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Yes Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party George F. Hatch, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George R Hatch, MD University of Southern California
PRS Account University of Southern California
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP