Impact on Elderly Skin Due to Wet Pad Application.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The test pads is to both forearms of the participants. Participants will be blinded to the test pad type. In total 4 pads are applied per participant. The test pads are either Dry (control), 50% or at 100% capacity. Dry and 50% pads are applied once, 100% capacity twice. This to allow one pad for recovery measurement and one for water profile measurement. Pad location will be randomized.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention arm

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

Group Type EXPERIMENTAL

Pads

Intervention Type OTHER

Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.

Interventions

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Pads

Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes