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Completed

NCT Number: NCT07164898

How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier

The main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.

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Key information

Conditions

Incontinence-associated Dermatitis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essity Study Site

Mölndal, 43131, 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

Test patches

Device

Patches (incontinence product cut outs) either dry, 50% saturated with water or 100% saturated with water applied to the forearm and worn for 2 hours

Primary outcomes

  1. Change in Trans Epidermal Water loss (TEWL)

    Time frame: 2 hours

    TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL.

Secondary outcomes

  1. Change in skin hydration

    Time frame: 2 hours

    Skin hydration (SH) as measured with moisture meter instrument under the test and control patches. Measure in arbitrary units (a.u).

  2. Change in skin surface pH

    Time frame: 2 hours

    The pH change under the dry/wet patches are measured and compared.

  3. Change skin water profile

    Time frame: 2 hours

    As measured Confocal raman microspectrometry. The water content (mass-% water) of skin at different depths is measured and compared for the skin under wet/dry patches.

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.

Acronym: DROPBOX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

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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