Evaluation of the Peel Force of New Adhesives From the Skin

Overview

This study investigates the impact and adhesion of new adhesives to the skin.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 4, 2017

Interventions

  • Other: Standard adhesive 1
    • This strip consists of a standard hydrocolloid adhesive found in ostomy products
  • Other: Standard adhesive 2
    • This strip consists of a standard hydrocolloid adhesive found in ostomy products
  • Other: Standard adhesive 3
    • This strip consists of a standard hydrocolloid adhesive found in ostomy products
  • Other: P-4
    • Newly developed adhesive P-4
  • Other: P-15
    • Newly developed adhesive P-14
  • Other: P-16
    • Newly developed adhesive P-8

Arms, Groups and Cohorts

  • Experimental: Testing of 6 adhesive strips
    • Each subject tests six adhesive strips on pre-striped skin. Standard adhesive 1 standard adhesive 2 Standard adhesive 3 P-4 P-15 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.

Clinical Trial Outcome Measures

Primary Measures

  • Peel force
    • Time Frame: 21 days
    • The peel force (N) needed to peel off adhesive strips from the skin

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Coloplast A/S
  • Provider of Information About this Clinical Study
    • Sponsor

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