Effect of an Antiseptic Solution on the Skin Microbiome | NCT05608382

Studies
Effect of an Antiseptic Solution on the Skin Microbiome

NCT05608382

Sponsor

Center for Innovation and Research Organization

Status

Completed

Last Update Posted

Nov 8, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Skin Diseases, Infectious

Interventions

sterile Phosphate Buffer Saline
SGW13

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2022Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

Mar 18, 2022Actual

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
sterile Phosphate Buffer Saline (PBS)	Placebo Comparator		Other: sterile Phosphate Buffer Saline
SGW13	Experimental		Other: SGW13

Name	Type	Description	Arm Group Labels	Other Names
sterile Phosphate Buffer Saline	Other	control group	sterile Phosphate Buffer Saline (PBS)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007239	Infections
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases