Impact on Elderly Skin Due to Wet Pad Application.

Not Applicable

Completed

• Conditions: Incontinence
• Interventions: Other: Pads

• Registration Number: NCT06248255
• Lead Sponsor: Essity Hygiene and Health AB

Brief Summary

The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Dry or wet pads are then added to the skin and worn for two hours. After a recovery period, the SkinSurfaceWaterLoss (SSWL) and skin hydration and water profile is measured. The study is conducted over a single visit. Pads on the arms consist of incontinence product cutouts and are loaded to 50% or 100% capacity. The endpoints are the changes in stratum corneum as measured by the instruments during the visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Arm && Interventions

Group	Intervention	Description
Intervention arm	Pads	Single arm study, all participants get pads applied to their forearms

Primary Outcome Measures

Name	Time	Method
Change in Skin water profile	2 hours	As measured Confocal raman microspectometry. The water content of skin at different depths.
Change Trans Epidermal Water loss	2 hours	As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin
Change in skin hydration	2 hours	Skin hydration (SH) as measured with moisturemeter instrument

Secondary Outcome Measures

Name	Time	Method
Change in skin surface pH	2 hours	Skin surface pH measurement using pH meter

Trial Locations

Locations (1)

Essity Study Site; 🇸🇪 Mölndal, Sweden