Clinical trial NCT05756348: Durability of Two Skin Barrier Protectants (SBP)
Official title: An Evaluation of the Skin Protection Characteristics of Two Commercially Available Skin Barrier Protectants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Hydration in Healthy Volunteers
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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™").

Detailed description: Completion of informed consent and participant screening will be followed by a washout period of minimum 18 hours (wherein participants will be asked to avoid application of cleansers, lotions, or perfumes to both forearms and inner elbows) prior to the first visit (Visit 1) of the study. During Visit 1, study personnel will confirm that the washout period has been successfully completed. Participants will wash their forearms and inner elbows with a standardized soap and dry them using paper towels for each arm. After the participants' forearms and inner elbows have fully dried, study personnel will use a Corneometer® (which measures skin hydration) to record baseline measurements of the skin within 2-inch x 2-inch squares (starting about two inches above the wrist) marked with a non-toxic marker on the volar forearms and inner elbows of the participants. Thereafter, participants will be randomized to the two SBPs, Marathon® or Cavilon™ (designated SBP). The designated SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's dominant arm (as determined by the participant). The other SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's non-dominant arm. A distinct area of each volar forearm will be used as an "untreated control area". Corneometer® measurements will be taken again on the same day after the SBPs have been left to dry for at least one minute or have fully dried. Thereafter, subsequent measurements will be taken daily over a seven-day period with a two-day break over the weekend. Each participant will commence the study on Monday or Tuesday. This will permit daily readings for the first 72 hours, which is the more important window to evaluate SBP wear time. There will be a two-day break in measurements over the weekend, after which Corneometer® measurements will be taken either on Monday, or Monday and Tuesday, depending on the participants' start date. Participants will be allowed to bathe their arms using a standardized soap provided by the study personnel but will be asked to minimize scrubbing and any other abrasion of the volar forearms and inner elbows. In addition, participants will be instructed not to engage in activities, for eg, sports (eg, tennis) or holding a baby that may cause significant abrasion on one arm and not the other. On the last visit of the study (Visit 6), study personnel will take the last set of Corneometer® measurements. In addition, participants will also complete surveys regarding their experience with the SBPs on specific days during study participation.

The Corneometer® measurements will help determine the presence of the SBPs and their deterioration over time. Skin treated with the SBPs will typically have lower readings than untreated skin. As the SBPs break down, the corresponding readings are expected to rise.

Eligibility criteria: Inclusion Criteria:

* Individuals ≥ 18 years of age

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Duration
timeFrame: 7 Days - Baseline + 6 visits = 7
measure: Durability
timeFrame: 7 Days - Baseline + 6 visits = 7
Secondary outcomes:
measure: Participant Feedback 2
timeFrame: 1 day
measure: Participant Feedback
timeFrame: 2 Days
measure: Participant Feedback - Product Preference
timeFrame: 7 Days - Baseline + 6 visits = 7
Other outcomes:
Locations:
city: Northfield
country: United States
facility: Medline Industries, LP
state: Illinois
Study officials:
affiliation: Medline Industries, LP
name: Julie Miller
role: PRINCIPAL_INVESTIGATOR
References: