Impact on Elderly Skin Due to Wet Pad Application. | NCT06248255

Studies
Impact on Elderly Skin Due to Wet Pad Application.

NCT06248255

Sponsor

Essity Hygiene and Health AB

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Incontinence

Interventions

Pads

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2023Actual

Primary Completion Date

Feb 9, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Jan 31, 2024

First Submission Date that Met QC Criteria

Jan 31, 2024

First Posted Date

Feb 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental	Single arm study, all participants get pads applied to their forearms	Other: Pads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pads	Other	Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.	Intervention arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change Trans Epidermal Water loss	As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin	2 hours
Change in skin hydration	Skin hydration (SH) as measured with moisturemeter instrument	2 hours
Change in Skin water profile	As measured Confocal raman microspectometry. The water content of skin at different depths.	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in skin surface pH	Skin surface pH measurement using pH meter	2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shabira Abbas, PhD	Essity Hygiene and Health AB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Essity Study Site		Mölndal		SE40503	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.