Effect of an Antiseptic Solution on the Skin Microbiome

Completed · Not applicable

Conditions studied: Skin Diseases, Infectious

In brief

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.

Key facts

Study ID

NCT05608382

Run by

Center for Innovation and Research Organization

People needed

50

Starts

2022-03-07

Expected to finish

2022-03-18

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subject is in generally good health.
• Subject is willing to sign the Informed Consent form prior to study participation

You may not qualify if…

• 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.

Where it is running

• Center for Innovation and Research Organization — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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