Clinical trial NCT02299206: CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
Official title: Randomized, Double-Blind, Parallel Group, Non-Inferiority Clinical Trial of CeraVe Baby Diaper Rash Cream Compared to Desitin Maximum Strength Original Paste for Management of Diaper Dermatitis in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diaper Rash
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2014-11-24
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
timeFrame: 14 days
Secondary outcomes:
measure: Change in Physician Assessment Diaper Dermatitis Scores to Day 7
timeFrame: 7 days
measure: Parents/Caregivers Daily Scores Through Duration of the Study Period
timeFrame: 14 days
measure: Assessment of Tolerability by the Infant
timeFrame: 14 days
measure: Parent/Caregiver Rating of Satisfaction With Use of the Product
timeFrame: 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
city: Chicago
country: United States
facility: Lurie Children's Hospital Outpatient Clinic at Lincoln Park
state: Illinois
Study officials:
affiliation: Department of Der,matology, Feinberg School of Medicine, Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: