Adhesive Tape Trauma Evaluation of Two Gentle Tapes

NCT ID: NCT01354106

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-06-30

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.

Conditions

Adhesive Tape Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

3M Kind Removal Silicone Tape

investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.

Group Type: EXPERIMENTAL

Skin Trauma

Intervention Type: DEVICE

Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.

3M Micropore Medical Tape

Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.

Group Type: OTHER

Skin Trauma

Intervention Type: DEVICE

Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.

Interventions

Skin Trauma

Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.

Intervention Type: DEVICE

Other Intervention Names

3M Micropore; 3M Kind Removal Silicone Tape - Investigational tape

Eligibility 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).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary L Grove, PhD

Role: PRINCIPAL_INVESTIGATOR

cyberDERM

Locations

cyberDERM

Broomall, Pennsylvania, United States

Countries

United States

Other Identifiers

EM-05-012247

Identifier Type: -

Identifier Source: org_study_id