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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Inf

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 Summary:

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.


Sponsor: Northwestern University

Current Primary Outcome: 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.


Original Primary Outcome: Change from baseline for the physician assessment DD 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.


Current Secondary Outcome:

  • 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.
  • 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
  • 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
  • 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.


Original Secondary Outcome:

  • 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.
  • 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 VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
  • 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
  • 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 By: Northwestern University

Dates:
Date Received: November 20, 2014
Date Started: December 2014
Date Completion: December 2017
Last Updated: March 24, 2017
Last Verified: February 2017