Status:
COMPLETED
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
3M
Conditions:
Skin (FLACC Scores of Test Subjects) After Tape Removal
Eligibility:
All Genders
6-4 years
Phase:
NA
Brief Summary
The objective of this study is to determine the relative gentleness of a new medical tape.
Detailed Description
The objective of this study is to determine the relative gentleness of a new medical tape. A three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and lab...
Eligibility Criteria
Inclusion
- Subjects will be infants or children of either gender who meet the following 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 (48 months)
- Who have a Fitzpatrick Skin Type of I, II or III
- Whose parent or legal representative 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 or legal representative agrees to sponge bathe their child during the study but agrees to not bathe their child 1 hour before each visit.
- Whose parent or legal representative agrees to not soak the tape during a sponge bath. If the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing).
- Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization.
Exclusion
- Who are known to be developmentally delayed
- Who have any known allergy or sensitivity to tapes
- Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
- 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 2 weeks prior to the start of the study
- Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
- Has participated in any study in the last 2 weeks, or are currently participating in another study, or are scheduled to participate in another study during this study period.
- Has any other skin disorders that, in the opinion of the investigator, will interfere with the study results or will increase undue risk for the child.
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03470012
Start Date
January 16 2018
End Date
March 20 2018
Last Update
October 2 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
cyberDERM, inc.
Broomall, Pennsylvania, United States, 19008