N/A
N=42
Durability of Two Skin Barrier Protectants (SBP)
Skin Hydration in Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05756348 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Duration — 36.71; 36.31; 7.95; 20.98 arbitrary units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration |
36.71; 36.31; 7.95; 20.98; 9.58; 17.00 | — |
| PRIMARY Durability |
3.00; 4.49; 1.37; 2.70; -0.59; 2.53 | — |
| SECONDARY Participant Feedback 2 |
3; 10; 11; 18; 0; 8 | — |
| SECONDARY Participant Feedback |
36; 6; 37; 5; 10; 32 | — |
| SECONDARY Participant Feedback - Product Preference |
7; 35 | — |
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™").
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.
Data sourced from ClinicalTrials.gov (NCT05756348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.