This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study. Location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will be asked to complete the daily diary for each day of the study. Visit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days. Visit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern University Department of Dermatology
Chicago, Illinois, United States
Lurie Children's Hospital Outpatient Clinic at Lincoln Park
Chicago, Illinois, United States
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Time frame: 14 days
Change in Physician Assessment Diaper Dermatitis Scores to Day 7
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Time frame: 7 days
Parents/Caregivers Daily Scores Through Duration of the Study Period
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Time frame: 14 days
Assessment of Tolerability by the Infant
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Time frame: 14 days
Parent/Caregiver Rating of Satisfaction With Use of the Product
Parents/caregivers will be given a questionnaire rating the use of the study products.
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.