Evaluation of the Peel Force of New Adhesives From the Skin
NCT ID: NCT03200444
Last Updated: 2025-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2017-07-03
2020-06-30
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
BASIC_SCIENCE
NONE
Study Groups
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Testing of 6 adhesive strips
Each subject tests six adhesive strips on pre-striped skin.
1. Standard adhesive 1
2. standard adhesive 2
3. Standard adhesive 3
4. P-4
5. P-15
6. P-16
The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits.
Standard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 3
This strip consists of a standard hydrocolloid adhesive found in ostomy products
P-4
Newly developed adhesive P-4
P-15
Newly developed adhesive P-14
P-16
Newly developed adhesive P-8
Interventions
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Standard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 3
This strip consists of a standard hydrocolloid adhesive found in ostomy products
P-4
Newly developed adhesive P-4
P-15
Newly developed adhesive P-14
P-16
Newly developed adhesive P-8
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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Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP267_01
Identifier Type: -
Identifier Source: org_study_id
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