Clinical trial NCT05608382: Effect of an Antiseptic Solution on the Skin Microbiome
Official title: Effect of an Antiseptic Solution on the Skin Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases, Infectious
Lead sponsor: Center for Innovation and Research Organization
Sponsor class: NETWORK
First posted: 2022-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

A subject may be eligible for study participation if all of the following criteria are met:

1. Subject is male or female greater than 18 years of age.
2. Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
3. 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).
4. Subject is willing to have materials applied and follow the protocol.
5. 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 \[2 hours\]).
6. Subject agrees to refrain from getting a bath/shower before T3 (24 h).
7. 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.
8. Subject is able to follow directions as outlined in the protocol and anticipates being available for all study visits.
9. Subject is willing to participate in all study evaluations.
10. Subject is in generally good health.
11. Subject is willing to sign the Informed Consent form prior to study participation

Exclusion Criteria:

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

Primary outcomes:
measure: Colony Forming Unit (CFU) count
timeFrame: 5 minutes
measure: Colony Forming Unit (CFU) count
timeFrame: 2 hours
measure: Colony Forming Unit (CFU) count
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Innovation and Research Organization
state: Pennsylvania
Study officials:
affiliation: Center for Innovation and Research Organization
name: Javad Parvizi, MD
role: PRINCIPAL_INVESTIGATOR
References: