Adhesive Tape Trauma Evaluation of Two Gentle Tapes

September 30, 2024 updated by: Solventum US LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • cyberDERM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Trauma
Time Frame: 24 hours

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Gary L Grove, PhD, cyberDERM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimated)

May 16, 2011

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-05-012247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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