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.

Age range6 Months – 4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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.

NCT IDNCT03470012

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-23

Results submitted2019-07-01

Who can participate

Age range6 Months – 4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.