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Adhesive Tape Trauma Evaluation of Two Gentle Tapes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01354106
First received: May 13, 2011
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Adhesive Tape Trauma
 Device: Skin Trauma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Skin Trauma [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    Expert grader using Erythema/Edema Scale 0=No visible response

    1. mild response
    2. moderate response
    3. severe response
    4. extreme response


Enrollment: 26
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3M Kind Removal Silicone Tape
investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.
 Device: Skin Trauma
Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
Other Names:
  • 3M Micropore
  • 3M Kind Removal Silicone Tape - Investigational tape
3M Micropore Medical Tape
Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.
 Device: Skin Trauma
Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
Other Names:
  • 3M Micropore
  • 3M Kind Removal Silicone Tape - Investigational tape

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.

  Eligibility

Ages Eligible for Study:   6 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
  2. Who are between the ages of 6 months - 4 years of age
  3. Who has a Fitzpatrick Skin Type of I, II or III
  4. 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
  5. Whose parent is willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Who are known to be developmentally delayed
  2. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
  3. 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.
  4. Who have had a strep infection within the past 2 weeks
  5. Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
  6. Who have allergies to isocyanates, or acrylate adhesive products
  7. 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354106

Locations
United States, Pennsylvania
cyberDERM
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Gary L Grove, PhD cyberDERM
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01354106     History of Changes
Other Study ID Numbers: EM-05-012247
Study First Received: May 13, 2011
Results First Received: July 20, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
Skin condition after wear

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013