Effect of an Antiseptic Solution on the Skin Microbiome

Skin Diseases, Infectious Clinical Trial

Official title:

Effect of an Antiseptic Solution on the Skin Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608382
• Other study ID #: SGW2022
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: March 18, 2022

Study information

• Verified date: October 2022
• Source: Center for Innovation and Research Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 18, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Skin Diseases
• Skin Diseases, Infectious

Intervention

Other:
• sterile Phosphate Buffer Saline
control group
• SGW13
active comparator

Locations

Country	Name	City	State
United States	Center for Innovation and Research Organization	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovation and Research Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colony Forming Unit (CFU) count	Comparison of the number of CFUs counted for each treatment arm	5 minutes
Primary	Colony Forming Unit (CFU) count	Comparison of the number of CFUs counted for each treatment arm	2 hours
Primary	Colony Forming Unit (CFU) count	Comparison of the number of CFUs counted for each treatment arm	24 hours