Durability of Two Skin Barrier Protectants (SBP)

NCT05756348 | Completed Results FDA Device

• 1 other identifier: MED-2022-DIV71-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™").

Conditions

Skin Hydration in Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Duration

  To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.

  7 Days - Baseline + 6 visits = 7

• Durability

  To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.

  7 Days - Baseline + 6 visits = 7

Secondary Outcomes (3)

• Participant Feedback 2

  1 day

• Participant Feedback

  2 Days

• Participant Feedback - Product Preference

  7 Days - Baseline + 6 visits = 7

Study Arms (1)

receives both product

OTHER

all participants receive both products under evaluation.

Device: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant

Interventions

Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant DEVICE

All participants will receive both device interventions listed above.

receives both product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥ 18 years of age

You may not qualify if:

• Individuals have skin conditions that might interfere with Corneometer® measurements, including rash, irritation, sunburn, tattoo, birthmark, any other dermal irregularities on the left or right volar forearm or inner elbow.
• Individuals have excessive hair on the left or right volar forearm or inner elbow as determined by study personnel.
• Individuals have a self-reported allergy/sensitivity to ingredients present in either of the SBPs, components of the soap used for bathing, or the exam gloves and non-toxic marker used in the study.
• Individuals are pregnant.
• Individuals whose self-reported activities may affect friction on one arm more than the other (eg, sports like tennis or holding a baby where one arm is used more routinely than the other).
• Individuals who are able to identify the manufacturer of the SBPs included in the study.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Medline Industries, LP

Northfield, Illinois, 60093, United States

Location

Results Point of Contact

• Title: Julie Miller
• Organization: Medline Industries, LP

jamiller@medline.com

630-418-6891

Study Officials

• Julie Miller

  Medline Industries, LP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: March 6, 2023
• Study Start: October 6, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)