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Investigating the Adhesion of New Adhesive to the Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439176
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE January 15, 2018
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Adhesion of New Adhesive to the Skin
Official Title  ICMJE A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Ileostomy - Stoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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

Interventions:
  • Other: Standard adhesive 1
  • Other: Standard adhesive 2
  • Other: PL4
  • Other: PL16-L
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: February 19, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have given written informed consent
  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:

  1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439176
Other Study ID Numbers  ICMJE CP267_3_5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lene F Nielsen Head of the pre-clinical department
PRS Account Coloplast A/S
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP