Impact on Elderly Skin Due to Wet Pad Application.

Essity

Status: Completed

Conditions: Incontinence

Treatments: Other: Pads

Study type: Interventional

Funder types: Industry

Identifiers

NCT06248255

DROPBOX

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Intervention arm

Experimental group

Description:

Single arm study, all participants get pads applied to their forearms

Treatment:

Other: Pads