Effect of an Antiseptic Solution on the Skin Microbiome

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases, Infectious
• Intervention / Treatment: Other: sterile Phosphate Buffer Saline; Other: SGW13

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Center for Innovation and Research Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sterile Phosphate Buffer Saline (PBS)	Other: sterile Phosphate Buffer Saline; control group
Experimental: SGW13	Other: SGW13; active comparator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center for Innovation and Research Organization
• Investigators: Principal Investigator: Javad Parvizi, MD, Center for Innovation and Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases
• Other Study ID Numbers: SGW2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No