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

Diaper Rash Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02299206
• Other study ID #: ASP05012014
• Status: Terminated
• Phase: N/A
• First received: November 20, 2014
• Last updated: February 13, 2018
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Diaper Rash

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Lurie Children's Hospital Outpatient Clinic at Lincoln Park	Chicago	Illinois
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.	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	Change in Physician Assessment Diaper Dermatitis Scores to Day 7	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
Secondary	Parents/Caregivers Daily Scores Through Duration of the Study Period	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
Secondary	Assessment of Tolerability by the Infant	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
Secondary	Parent/Caregiver Rating of Satisfaction With Use of the Product	Parents/caregivers will be given a questionnaire rating the use of the study products.	14 days

External Links

•   Information on study