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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06248255
Other study ID # DROPBOX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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