Impact on Elderly Skin Due to Wet Pad Application.

Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06248255
• Other study ID #: DROPBOX
• Status: Completed
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: Essity Hygiene and Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Incontinence

Intervention

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

Locations

Country	Name	City	State
Sweden	Essity Study Site	Mölndal

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in skin hydration	Skin hydration (SH) as measured with moisturemeter instrument	2 hours
Primary	Change in Skin water profile	As measured Confocal raman microspectometry. The water content of skin at different depths.	2 hours
Secondary	Change in skin surface pH	Skin surface pH measurement using pH meter	2 hours