Status:
TERMINATED
CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Diaper Rash
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 Stre...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Healthy children (except for diaper dermatitis) between 3 and 18 months of age
- Wearing diapers 24 hours per day
- Clinical irritant diaper dermatitis
- Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity)
- Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded
- No alteration of current product usage for creams, lotions, ointments, powders, soap, laundry detergents, and fabric softeners
- A parent or guardian of minors must sign the approved Institutional Review Board consent form prior to the conduct of any study-related procedures
Exclusion
- Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation
- Does not wear diapers 24 hours per day or currently being toilet trained
- Active diagnosis or history of dermatological conditions other than diaper rash that may affect study
- Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor)
- Previous allergic reaction or known sensitivity to ingredients in study agents
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02299206
Start Date
December 1 2014
End Date
July 1 2016
Last Update
March 13 2018
Active Locations (3)
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1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-2991
2
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
3
Lurie Children's Hospital Outpatient Clinic at Lincoln Park
Chicago, Illinois, United States, 60614