Adhesive Tape Trauma Evaluation of Two Gentle Tapes

Study Overview
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Brief Summary
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The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Detailed Description
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The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Official Title
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Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects

Conditions
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Adhesive Tape Trauma

Intervention / Treatment
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* Device: Skin Trauma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema Who are between the ages of 6 months - 4 years of age Who has a Fitzpatrick Skin Type of I, II or III Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date Whose parent is willing to sign the Informed Consent Form. Exclusion Criteria: Who are known to be developmentally delayed Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study. Who have had a strep infection within the past 2 weeks Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions Who have allergies to isocyanates, or acrylate adhesive products Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3M Kind Removal Silicone Tape<br>investigational medical Silicone tape, 1 x 1.5 sample, applied on time, worn for 24 hours. | Device: Skin Trauma<br>* Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.<br>* Other names: 3M Kind Removal Silicone Tape - Investigational tape;|
| Other: 3M Micropore Medical Tape<br>Commercially available Medical Paper Tape, 1 x 1.5 sample, applied on time, worn for 24 hours. Study Control. | Device: Skin Trauma<br>* Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.<br>* Other names: 3M Kind Removal Silicone Tape - Investigational tape;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Trauma | Expert grader using Erythema/Edema Scale 0=No visible response mild response moderate response severe response extreme response | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin condition after wear