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

Essity

Status

Completed

Conditions

Incontinence-associated Dermatitis

Treatments

Device: Test patches

Study type

Interventional

Funder types

Industry

Identifiers

NCT07164898

C3197

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.