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Completed

NCT Number: NCT05608382

Effect of an Antiseptic Solution on the Skin Microbiome

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovation and Research Organization

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sterile Phosphate Buffer Saline

Other

control group

SGW13

Other

active comparator

Primary outcomes

  1. Colony Forming Unit (CFU) count

    Time frame: 5 minutes

    Comparison of the number of CFUs counted for each treatment arm

  2. Colony Forming Unit (CFU) count

    Time frame: 2 hours

    Comparison of the number of CFUs counted for each treatment arm

  3. Colony Forming Unit (CFU) count

    Time frame: 24 hours

    Comparison of the number of CFUs counted for each treatment arm

Sponsors and collaborators

Lead sponsor

Center for Innovation and Research Organization

Network

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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