Incontinence
Conditions
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.
Interventions
OTHERPads
Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Trans Epidermal Water loss | 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 |
| Change in skin hydration | 2 hours | Skin hydration (SH) as measured with moisturemeter instrument |
| Change in Skin water profile | 2 hours | As measured Confocal raman microspectometry. The water content of skin at different depths. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin surface pH | 2 hours | Skin surface pH measurement using pH meter |
Countries
Sweden
Outcome results
None listed