Adhesive Tape Trauma Evaluation of Two Gentle Tapes
Primary Purpose
Adhesive Tape Trauma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Trauma
Sponsored by
About this trial
This is an interventional basic science trial for Adhesive Tape Trauma focused on measuring Skin condition after wear
Eligibility Criteria
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).
Sites / Locations
- cyberDERM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
3M Kind Removal Silicone Tape
3M Micropore Medical Tape
Arm Description
investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.
Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.
Outcomes
Primary Outcome Measures
Skin Trauma
Expert grader using Erythema/Edema Scale 0=No visible response
mild response
moderate response
severe response
extreme response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01354106
Brief Title
Adhesive Tape Trauma Evaluation of Two Gentle Tapes
Official Title
Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Tape Trauma
Keywords
Skin condition after wear
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3M Kind Removal Silicone Tape
Arm Type
Experimental
Arm Description
investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.
Arm Title
3M Micropore Medical Tape
Arm Type
Other
Arm Description
Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.
Intervention Type
Device
Intervention Name(s)
Skin Trauma
Other Intervention Name(s)
3M Micropore, 3M Kind Removal Silicone Tape - Investigational tape
Intervention Description
Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
Primary Outcome Measure Information:
Title
Skin Trauma
Description
Expert grader using Erythema/Edema Scale 0=No visible response
mild response
moderate response
severe response
extreme response
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L Grove, PhD
Organizational Affiliation
cyberDERM
Official's Role
Principal Investigator
Facility Information:
Facility Name
cyberDERM
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
12. IPD Sharing Statement
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Adhesive Tape Trauma Evaluation of Two Gentle Tapes
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