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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06464770
Other study ID # STUDY00020250
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2027

Study information

Verified date June 2024
Source University of Washington
Contact Anastasia Whitson
Phone 206-755-7847
Email whitsa@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is: Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different. Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - English speaking Exclusion Criteria: - Self report very sensitive skin - Allergic to chlorhexidine - Used antibiotics in the last three months - Used acne treatment in the last three months - Wounds on your shoulders

Study Design


Intervention

Drug:
Chlorhexidine Gluconate
Test Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at lower pressure (similar to a gentle wipe) for 30 seconds Control Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at higher pressure (similar to a massage) for 30 seconds

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure 60 Minutes After ChloraPrep Wash
Primary Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure 60 Minutes After ChloraPrep Wash
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