Effect of an Antiseptic Solution on the Skin Microbiome

NCT ID: NCT05608382

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-03-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sterile Phosphate Buffer Saline (PBS)

Group Type: PLACEBO_COMPARATOR

sterile Phosphate Buffer Saline

Intervention Type: OTHER

control group

SGW13

Group Type: EXPERIMENTAL

SGW13

Intervention Type: OTHER

active comparator

Interventions

sterile Phosphate Buffer Saline

control group

Intervention Type: OTHER

SGW13

active comparator

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Innovation and Research Organization

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javad Parvizi, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Innovation and Research Organization

Locations

Center for Innovation and Research Organization

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

SGW2022

Identifier Type: -

Identifier Source: org_study_id