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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299206
Recruitment Status : Terminated (Principal Investigator and sponsor agreed to termination.)
First Posted : November 24, 2014
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Amy Paller, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Diaper Rash Drug: CeraVe Baby Diaper Rash Cream Drug: Desitin Maximum Strength Original Paste Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Zinc oxide

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 Name: 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 Name: Desitin MSOP NDC Code: 58232-0721




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299206


Locations
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United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-2991
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Lurie Children's Hospital Outpatient Clinic at Lincoln Park
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Northwestern University
Bausch Health Americas, Inc.
Investigators
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Principal Investigator: Amy Paller, MD Department of Der,matology, Feinberg School of Medicine, Northwestern University

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Responsible Party: Amy Paller, Professor and Chair of Department of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT02299206    
Other Study ID Numbers: ASP05012014
First Posted: November 24, 2014    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Dermatitis
Diaper Rash
Skin Diseases
Dermatitis, Irritant
Dermatitis, Contact
Skin Diseases, Eczematous
Zinc Oxide
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs