Investigating the Adhesion of New Adhesive to the Skin | NCT03439176

Studies
Investigating the Adhesion of New Adhesive to the Skin

NCT03439176

Sponsor

Coloplast A/S

Status

Unknown status

Last Update Posted

Jan 27, 2020Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Ileostomy - Stoma

Interventions

Standard adhesive 1
Standard adhesive 2
PL4
PL16-L

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jan 31, 2018

First Submission Date that Met QC Criteria

Feb 19, 2018

First Posted Date

Feb 20, 2018Actual

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

Jan 22, 2020

Last Update Posted Date

Jan 27, 2020Actual

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 adhesion of the new adhesive strips is investigated on healthy volunteers

Detailed Description

Inclusion visit:

Introduction to the study
Inclusion in study
Baseline information is obtained
Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
Adhesive strips are weighted and applied
Potential shower/bicycle exercise (max 60 minutes)
Adhesive strips are removed at pre-defined timeslots (peel force measured)
Discomfort when strip was peeled of is evaluated by subject (VAS)
Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
Acclimatization ½
Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
Adhesive strips are weighed
Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test of new adhesive strips	Experimental	The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L	Other: Standard adhesive 1 Other: Standard adhesive 2 Other: PL4 Other: PL16-L

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard adhesive 1	Other	This strip contains a standard hydrocolloid adhesive found in ostomy devices	Test of new adhesive strips

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Swelling of the adhesive	Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have intact skin on the area used in the investigation

Exclusion Criteria:

Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
Are pregnant or breastfeeding
Have dermatological problems in the abdominal area (assessed by investigator)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene F Nielsen	Head of the pre-clinical department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coloplast A/S		Humlebæk		3050	Denmark

Type	Date	Date Unknown
Release	Sep 19, 2023
Reset	Mar 21, 2024

Submission Tracking

Estimated Results First Submitted Date

Sep 19, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 19, 2023			Mar 21, 2024