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Effect of an Antiseptic Solution on the Skin Microbiome

Primary Purpose

Skin Diseases, Infectious

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sterile Phosphate Buffer Saline
SGW13
Sponsored by
Center for Innovation and Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Infectious

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Innovation and Research Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

sterile Phosphate Buffer Saline (PBS)

SGW13

Arm Description

Outcomes

Primary Outcome Measures

Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm
Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm
Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm

Secondary Outcome Measures

Full Information

First Posted
November 1, 2022
Last Updated
November 1, 2022
Sponsor
Center for Innovation and Research Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05608382
Brief Title
Effect of an Antiseptic Solution on the Skin Microbiome
Official Title
Effect of an Antiseptic Solution on the Skin Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovation and Research Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sterile Phosphate Buffer Saline (PBS)
Arm Type
Placebo Comparator
Arm Title
SGW13
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
sterile Phosphate Buffer Saline
Intervention Description
control group
Intervention Type
Other
Intervention Name(s)
SGW13
Intervention Description
active comparator
Primary Outcome Measure Information:
Title
Colony Forming Unit (CFU) count
Description
Comparison of the number of CFUs counted for each treatment arm
Time Frame
5 minutes
Title
Colony Forming Unit (CFU) count
Description
Comparison of the number of CFUs counted for each treatment arm
Time Frame
2 hours
Title
Colony Forming Unit (CFU) count
Description
Comparison of the number of CFUs counted for each treatment arm
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Parvizi, MD
Organizational Affiliation
Center for Innovation and Research Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Innovation and Research Organization
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Effect of an Antiseptic Solution on the Skin Microbiome

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