Effect of an Antiseptic Solution on the Skin Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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Effect of an Antiseptic Solution on the Skin Microbiome

Conditions
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Skin Diseases, Infectious

Intervention / Treatment
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* Other: sterile Phosphate Buffer Saline
* Other: SGW13


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sterile Phosphate Buffer Saline (PBS)<br> | Other: sterile Phosphate Buffer Saline<br>* control group<br>|
| Experimental: SGW13<br> | Other: SGW13<br>* active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colony Forming Unit (CFU) count | Comparison of the number of CFUs counted for each treatment arm | 5 minutes | 
| Colony Forming Unit (CFU) count | Comparison of the number of CFUs counted for each treatment arm | 2 hours | 
| Colony Forming Unit (CFU) count | Comparison of the number of CFUs counted for each treatment arm | 24 hours |