How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier

Not Applicable

Completed

• Conditions: Incontinence-associated Dermatitis

• Registration Number: NCT07164898
• Lead Sponsor: Essity Hygiene and Health AB

Brief Summary

The main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-13
• Primary Completion: 2024-02-09
• Study Completion: 2024-04-30
• Study First Submitted: 2025-08-15
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Men and women ≥ 65 years.
2. Mentally and physically able to participate in this study.
3. Written informed consent to participate in this study.
4. Intact skin on the volar forearms without skin irritation.

Exclusion Criteria

1. Have any known allergies or intolerances to one or several components of the absorbing incontinence product.
2. Suffer from excessive sweating, hyperhidrosis.
3. Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
4. Not be of childbearing potential.
5. Have an alcohol and/or drug dependency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Trans Epidermal Water loss (TEWL)	2 hours	TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2\*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL.

Secondary Outcome Measures

Name	Time	Method
Change in skin hydration	2 hours	Skin hydration (SH) as measured with moisture meter instrument under the test and control patches. Measure in arbitrary units (a.u).
Change in skin surface pH	2 hours	The pH change under the dry/wet patches are measured and compared.
Change skin water profile	2 hours	As measured Confocal raman microspectrometry. The water content (mass-% water) of skin at different depths is measured and compared for the skin under wet/dry patches.

Trial Locations

Locations (1)

Essity Study Site; 🇸🇪 Mölndal, Sweden