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OpenTrials
Completed

NCT Number: NCT06248255

Impact on Elderly Skin Due to Wet Pad Application.

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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Key information

Conditions

Incontinence

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essity Study Site

Mölndal, SE40503, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pads

Other

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

Primary outcomes

  1. Change Trans Epidermal Water loss

    Time frame: 2 hours

    As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin

  2. Change in skin hydration

    Time frame: 2 hours

    Skin hydration (SH) as measured with moisturemeter instrument

  3. Change in Skin water profile

    Time frame: 2 hours

    As measured Confocal raman microspectometry. The water content of skin at different depths.

Secondary outcomes

  1. Change in skin surface pH

    Time frame: 2 hours

    Skin surface pH measurement using pH meter

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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