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

NCT ID: NCT02299206

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-07-31

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 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.

Conditions

Diaper Rash

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CeraVe Baby Diaper Rash Cream

Healthy 3-18 months old infants with mild to moderate diaper dermatitis.

Group Type: EXPERIMENTAL

CeraVe Baby Diaper Rash Cream

Intervention Type: DRUG

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

Healthy 3-18 months old infants with mild to moderate diaper dermatitis.

Group Type: EXPERIMENTAL

Desitin Maximum Strength Original Paste

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

CeraVe BDRC NDC Code: 0187-2221; Desitin MSOP NDC Code: 58232-0721

Eligibility 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Professor and Chair of Department of Dermatology, Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Der,matology, Feinberg School of Medicine, Northwestern University

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Lurie Children's Hospital Outpatient Clinic at Lincoln Park

Chicago, Illinois, United States

Countries

United States

Other Identifiers

ASP05012014

Identifier Type: -

Identifier Source: org_study_id