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Completed

NCT Number: NCT01354106

Adhesive Tape Trauma Evaluation of Two Gentle Tapes

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.

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Key information

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

cyberDERM

Broomall, Pennsylvania, 19008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Skin Trauma

Device

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

Primary outcomes

  1. Skin Trauma

    Time frame: 24 hours

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

    • mild response
    • moderate response
    • severe response
    • extreme response

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 16, 2011
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.