Impact on Elderly Skin Due to Wet Pad Application.

NCT06248255 | Completed

• 1 other identifier: DROPBOX
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in skin surface pH

  2 hours

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Other: Pads

Interventions

Pads OTHER

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

Intervention arm

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, SE40503, Sweden

Location

Study Officials

• Shabira Abbas, PhD

  Essity Hygiene and 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: 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.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: December 14, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 28, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)