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

NCT07164898 | Completed

• 1 other identifier: C3197
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence-associated Dermatitis

Keywords

"skin barrier" "absorbing incontinence product" elderly

Outcome Measures

Primary Outcomes (1)

• Change in Trans Epidermal Water loss (TEWL)

  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.

  2 hours

Secondary Outcomes (3)

• Change in skin hydration

  2 hours

• Change in skin surface pH

  2 hours

• Change skin water profile

  2 hours

Study Arms (1)

Test patches

EXPERIMENTAL

Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula.

Device: Test patches

Interventions

Test patches DEVICE

Patches (incontinence product cut outs) either dry, 50% saturated with water or 100% saturated with water applied to the forearm and worn for 2 hours

Test patches

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Essity Study Site

Mölndal, 43131, Sweden

Location

Study Officials

• Shabira Abbas, PhD

  Essity Hygiene & Health AB

  PRINCIPAL INVESTIGATOR

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

Model Details: Healthy volunteers get dry or wet test patches applied to the skin of the forearms. The cut outs are either dry or wetted with saline to 50% or 100% capacity. In total two pads are applied per forearm.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 10, 2025
• Study Start: December 13, 2023
• Primary Completion: February 9, 2024
• Study Completion: April 30, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)