Effect of an Antiseptic Solution on the Skin Microbiome

NCT05608382 | Completed

• 1 other identifier: SGW2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Diseases, Infectious

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

sterile Phosphate Buffer Saline (PBS)

PLACEBO COMPARATOR

Other: sterile Phosphate Buffer Saline

SGW13

EXPERIMENTAL

Other: SGW13

Interventions

sterile Phosphate Buffer Saline OTHER

control group

sterile Phosphate Buffer Saline (PBS)

SGW13 OTHER

active comparator

SGW13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Innovation and Research Organization: lead

Study Sites (1)

Center for Innovation and Research Organization

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Skin Diseases, Infectious

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Javad Parvizi, MD

  Center for Innovation and Research Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: March 7, 2022
• Primary Completion: March 15, 2022
• Study Completion: March 18, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-10

Locations

US (1)