Study on Adhesion Properties of Three Different Adhesives

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Application of adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |