CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
Status:
Terminated
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Northwestern University
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.