Impact on Elderly Skin Due to Wet Pad Application.

Impact to Skin Due to Wet Pad Application. Skin Status and Change in the Stratum Corneum as Measured With 4 Instruments in an Elderly Population.

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.

Study Overview

• Status: Completed
• Conditions: Incontinence
• Intervention / Treatment: Other: Pads

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Mölndal, Sweden, SE40503
    • Essity Study site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Single arm study, all participants get pads applied to their forearms	Other: Pads; Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin surface pH	Skin surface pH measurement using pH meter	2 hours

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Shabira Abbas, PhD, Essity Hygiene and Health AB

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DROPBOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No