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Topical Treatment and Prevalence of P. Acnes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Surgical Site Infection
Interventions Drug: Clindamycin 1% Gel
Drug: Benzoyl peroxide 5% gel
Drug: BenzaClin 5%-1% Topical Gel
Enrollment 12
Recruitment Details  
Pre-assignment Details All 12 patients received each of the 4 study arms.
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description
  1. Negative Control
  2. Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
  3. Topical clindamycin alone using Clindamycin 1% Gel
  4. BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
29.4
(26 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
Hide Description Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Negative Control Benzoyl Peroxide 5% Topical Gel Clindamycin 1% Topical Gel Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel
Hide Arm/Group Description:
The participants did not receive treatment in this quadrant.
This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel
This quadrant of the participants' back received Clindamycin 1% topical gel
This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: participants
10 12 10 10
Time Frame 24 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Clindamycin Alone Benzoyl Peroxide Alone Clindamycin and Benzoyl Peroxide
Hide Arm/Group Description No topical treatment

topical clindamycin alone using Clindamycin 1% Gel

Clindamycin 1% Gel: topical clindamycin

topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

Benzoyl peroxide 5% gel: topical benzoyl peroxide

Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel

BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together

All-Cause Mortality
Control Clindamycin Alone Benzoyl Peroxide Alone Clindamycin and Benzoyl Peroxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Control Clindamycin Alone Benzoyl Peroxide Alone Clindamycin and Benzoyl Peroxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Clindamycin Alone Benzoyl Peroxide Alone Clindamycin and Benzoyl Peroxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. George Hatch
Organization: Keck Medical Center of USC
Phone: 323-442-5860
EMail: ghatch.md@gmail.com
Publications:
Layout table for additonal information
Responsible Party: George F. Hatch, University of Southern California
ClinicalTrials.gov Identifier: NCT03257202    
Other Study ID Numbers: HS-17-00319
First Submitted: August 1, 2017
First Posted: August 22, 2017
Results First Submitted: June 20, 2019
Results First Posted: November 13, 2019
Last Update Posted: November 13, 2019