Clinical trial NCT03470012: Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
Official title: Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin (FLACC Scores of Test Subjects) After Tape Removal
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2018-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 laboratory assessments was used. One pre-study visit took place up to 7 days prior to the start of the study. The study was conducted over two days with one tape sample applied and removed. Assessments were taken on the final day. This was to mimic a normal tape application in health care practice.

Eligibility criteria: Inclusion Criteria: Subjects will be infants or children of either gender who meet the following 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 (48 months)
3. Who have a Fitzpatrick Skin Type of I, II or III
4. 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
5. 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.
6. 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).
7. Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization.

Exclusion Criteria:

1. Who are known to be developmentally delayed
2. Who have any known allergy or sensitivity to tapes
3. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
4. 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
5. Who have had a strep infection within the 2 weeks prior to the start of the study
6. Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
7. 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.
8. 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Broomall
country: United States
facility: cyberDERM, inc.
state: Pennsylvania
Study officials:
affiliation: Study Investigator
name: Gary L Grove, PhD
role: PRINCIPAL_INVESTIGATOR
References: