Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test patches | Experimental | Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trans Epidermal Water loss (TEWL) | 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin hydration | Skin hydration (SH) as measured with moisture meter instrument under the test and control patches. Measure in arbitrary units (a.u). | 2 hours |
| Change in skin surface pH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shabira Abbas, PhD | Essity Hygiene & Health AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essity Study Site | Mölndal | 43131 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy volunteers get dry or wet test patches applied to the skin of the forearms. The cut outs are either dry or wetted with saline to 50% or 100% capacity. In total two pads are applied per forearm.
Not provided
Not provided
Not provided
Not provided
The pH change under the dry/wet patches are measured and compared.
| 2 hours |
| Change skin water profile | 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. | 2 hours |