Effect of an Antiseptic Solution on the Skin Microbiome

Center for Innovation and Research Organization1 site in 1 country50 target enrollmentMarch 7, 2022

ConditionsSkin Diseases, Infectious

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Diseases, Infectious
Sponsor: Center for Innovation and Research Organization
Enrollment: 50
Locations: 1
Primary Endpoint: Colony Forming Unit (CFU) count
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.

Registry

clinicaltrials.gov

Start Date

March 7, 2022

End Date

March 18, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Center for Innovation and Research Organization

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject may be eligible for study participation if all of the following criteria are met:
•Subject is male or female greater than 18 years of age.
•Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
•Subject does not have a history of skin disease (e.g scleroderma, vitiligo, psoriasis) or a chronic systemic disease affecting the skin (e.g systemic lupus erythematosus).
•Subject is willing to have materials applied and follow the protocol.
•Subject agrees to avoid exposure of the test sites to the sun, chemical product, clothes and to refrain from touching the area of application (for T0 \[baseline\], T1 \[5 minutes\], T2 \[2 hours\]).
•Subject agrees to refrain from getting a bath/shower before T3 (24 h).
•Subject agrees to avoid scrubbing, applying, and/or washing the test area with new soap, moistures, powders, lotions, cosmetic or toiletry products during the study.
•Subject is able to follow directions as outlined in the protocol and anticipates being available for all study visits.
•Subject is willing to participate in all study evaluations.

Exclusion Criteria

•Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
•Subject is immunologically compromised or has received specific topical treatment (antimicrobial or not-antimicrobial), during the last month.
•Subject reports a history of allergies to antiseptics.
•Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
•Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.