Investigating the Adhesion of New Adhesive to the Skin
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ClinicalTrials.gov Identifier: NCT03439176 |
Recruitment Status :
Enrolling by invitation
First Posted : February 20, 2018
Last Update Posted : January 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ileostomy - Stoma | Other: Standard adhesive 1 Other: Standard adhesive 2 Other: PL4 Other: PL16-L | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin |
Actual Study Start Date : | January 15, 2018 |
Actual Primary Completion Date : | February 15, 2018 |
Estimated Study Completion Date : | June 30, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Test of new adhesive strips
The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L |
Other: Standard adhesive 1
This strip contains a standard hydrocolloid adhesive found in ostomy devices Other: Standard adhesive 2 This strip contains a standard hydrocolloid adhesive found in ostomy devices Other: PL4 This strip contains a new adhesive Other: PL16-L This strip contains a new adhesive |
- Swelling of the adhesive [ Time Frame: 24 hours ]Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439176
Denmark | |
Coloplast A/S | |
Humlebæk, Denmark, 3050 |
Principal Investigator: | Lene F Nielsen | Head of the pre-clinical department |
Responsible Party: | Coloplast A/S |
ClinicalTrials.gov Identifier: | NCT03439176 |
Other Study ID Numbers: |
CP267_3_5 |
First Posted: | February 20, 2018 Key Record Dates |
Last Update Posted: | January 27, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |