- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299206
CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
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 Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Department of Dermatology
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Chicago, Illinois, United States, 60611-2991
- Ann & Robert H Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States, 60614
- Lurie Children's Hospital Outpatient Clinic at Lincoln Park
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
|
Experimental: Desitin Maximum Strength Original Paste
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
|
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy Paller, MD, Department of Der,matology, Feinberg School of Medicine, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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