CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants

February 13, 2018 updated by: Amy Paller, Northwestern University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology
      • Chicago, Illinois, United States, 60611-2991
        • Ann & Robert H Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60614
        • Lurie Children's Hospital Outpatient Clinic at Lincoln Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CeraVe Baby Diaper Rash Cream
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
Drug: CeraVe Baby Diaper Rash Cream
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.
Other Names:
  • CeraVe BDRC NDC Code: 0187-2221
Experimental: Desitin Maximum Strength Original Paste
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
Drug: Desitin Maximum Strength Original Paste
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.
Other Names:
  • Desitin MSOP NDC Code: 58232-0721

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
Time Frame: 14 days
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physician Assessment Diaper Dermatitis Scores to Day 7
Time Frame: 7 days
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.
7 days
Parents/Caregivers Daily Scores Through Duration of the Study Period
Time Frame: 14 days
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
14 days
Assessment of Tolerability by the Infant
Time Frame: 14 days
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
14 days
Parent/Caregiver Rating of Satisfaction With Use of the Product
Time Frame: 14 days
Parents/caregivers will be given a questionnaire rating the use of the study products.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: Amy Paller, MD, Department of Der,matology, Feinberg School of Medicine, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASP05012014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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