Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects (NCT03470012) | Clinical Trial Compass
CompletedNot Applicable
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
United States24 participantsStarted 2018-01-16
Plain-language summary
The objective of this study is to determine the relative gentleness of a new medical tape.
Who can participate
Age range
6 Months – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (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 criteria
. Who are known to be developmentally delayed
. Who have any known allergy or sensitivity to tapes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Face, Legs, Activity, Cry, Consolability (FLACC) Score.
Timeframe: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.
. 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.