Study on Adhesion Properties of Three Different Adhesives

A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers

This clinical investigation is a single centre, double blinded, case control study in healthy adult females. This study will be conducted in private rooms at Gentofte Hospital (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).

The investigation centre will enroll 39 subjects including a 20% drop out within a four (4) months period. The subject will not be enrolled before approval of investigation protocol by the local ethics committee.

The subjects need to meet the inclusion and exclusion criteria to be included in this clinical investigation. Each volunteer enrolled in the investigation can only participate once in a procedure. The testing period for each subject will be minimum 72 hours.

The principal investigator's qualifications will be verified through his/her CV. The principal investigator is required to be a medical doctor with at least one year's experience in using similar medical adhesives (e.g. by being experienced in using electrodes where medical adhesives are included) and at least one year's experience with clinical research. In addition, the investigator must be trained in GCP before the study is initiated.

If any subject withdraws from the study, they will not be replaced as drop-out rate is included in the sample size.

Subjects must show up for two sessions, in the first session six adhesives will be placed below the subjects bra. The adhesives will be removed after minimum 72 hours at the second visit. While wearing the adhesives the subjects must keep the investigational area dry. 24, 48 and 72 hours after placement of the adhesives, the subject is asked to completed a questionnaire.

The eCRF must be completed for each subject that has signed the Informed consent form (ICF) and enrolled into this clinical investigation.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Application of adhesive

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female Healthy Volunteers.
• Age 18 - 40 years old.
• Willing to attend two scheduled visits
• Able to assess itch and adherence at 24h, 48h and 72h.
• Provide written informed consent.

Exclusion Criteria:

• Non-intact skin barrier (e.g. eczema, rash, cut, scar tissue, wound, etc.).
• History of inflammatory skin diseases (e.g. atopic dermatitis or psoriasis).
• History of contact allergy
• Swimming or engaging in sport activities causing sweat during study peri-od. v. Use of medication (e.g. corticosteroids) which could affect skin reactions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adhesive 1; This arm investigates one type of silicone adhesive (3M2475P) on adult female skin.	Other: Application of adhesive; Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.
Active Comparator: Adhesive 2; This arm investigates one type of silicone adhesive (RX1449P) on adult female skin.	Other: Application of adhesive; Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.
Active Comparator: Adhesive 3; This arm investigates one type of silicone adhesive (PS-1243) on adult female skin.	Other: Application of adhesive; Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin adhesion rating	Rate of adhesion on a 5-point scale (no lift off the skin to deattached and completely off the skin)	Minimum 72 hours after application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Itch	Subject evaluation of itch during removal measured on visual analogue scale (0-10)	24, 48 and 72 hours after adsive application
Ease of removal	Ease of removal on 5-point scale (very difficult to very easy)	Minimum 72 hours after application
Pain during removal of adhesive	Subject evaluation of pain during removal measured on visual analogue scale (0-10)	Minimum 72 hours after application
Rate of skin reaction	Skin reaction rated on a scale from 0-7 (no evidence of irritation to strong reaction spreading beyond the application site)	Minimum 72 hours after application
Adhesive residue	Adhesioe residue left on skin after removal of adhesive (yes/no)	Minimum 72 hours after application

Collaborators and Investigators

• Sponsor: Ambu A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: CIS-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No