Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
NCT ID: NCT03619226
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2018-07-02
2018-07-04
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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test patch
two adhesive patches are applied to the abdominal area
test patch
the test patch consists of an adhesive patch
Interventions
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test patch
the test patch consists of an adhesive patch
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 evaluation
4. Have an abdominal area accessible for application of test product (assessed by investigator)
5. Negative pregnancy test for fertile women
6. Signed document claiming use of safe contraceptives for fertile women
Exclusion Criteria
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or 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 F Nielsen
Role: PRINCIPAL_INVESTIGATOR
Head of the pre-clinical department
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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CP284_1
Identifier Type: -
Identifier Source: org_study_id
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