Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
NCT ID: NCT03289013
Last Updated: 2018-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2017-09-11
2017-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
1. Standard adhesive 1
2. Standard adhesive 2
3. LT-2
4. LT-21
5. LT-25
6. 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Standard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
Standard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
LT-2
Newly developed adhesive
LT-21
Newly developed adhesive
LT-25
Newly developed adhesive
33-20
Newly developed adhesive
Interventions
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Standard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
Standard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
LT-2
Newly developed adhesive
LT-21
Newly developed adhesive
LT-25
Newly developed adhesive
33-20
Newly developed adhesive
Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation
Exclusion Criteria
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)
18 Years
ALL
Yes
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Lene Feldskov
Role: PRINCIPAL_INVESTIGATOR
Head of preclinical department
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP267_02
Identifier Type: -
Identifier Source: org_study_id
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