Adhesive Tape Trauma Evaluation of Two Gentle Tapes

Not Applicable

Completed

• Conditions: Adhesive Tape Trauma
• Interventions: Device: Skin Trauma

• Registration Number: NCT01354106
• Lead Sponsor: Solventum US LLC

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-07-20
• Results First Submitted QC: 2012-10-10
• Results First Posted: 2012-10-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3M Kind Removal Silicone Tape	Skin Trauma	investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.
3M Micropore Medical Tape	Skin Trauma	Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.

Primary Outcome Measures

Name	Time	Method
Skin Trauma	24 hours	Expert grader using Erythema/Edema Scale 0=No visible response; 1. mild response; 2. moderate response; 3. severe response; 4. extreme response

Trial Locations

Locations (1)

cyberDERM; 🇺🇸 Broomall, Pennsylvania, United States