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

NCT02299206 | Terminated Results DMC

• 1 other identifier: ASP05012014
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Diaper Rash

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Physician Assessment Diaper Dermatitis Scores to Day 7

  7 days

• Parents/Caregivers Daily Scores Through Duration of the Study Period

  14 days

• Assessment of Tolerability by the Infant

  14 days

• Parent/Caregiver Rating of Satisfaction With Use of the Product

  14 days

Study Arms (2)

CeraVe Baby Diaper Rash Cream

EXPERIMENTAL

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

Drug: CeraVe Baby Diaper Rash Cream

Desitin Maximum Strength Original Paste

EXPERIMENTAL

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

Drug: Desitin Maximum Strength Original Paste

Interventions

CeraVe Baby Diaper Rash Cream 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.

Also known as: CeraVe BDRC NDC Code: 0187-2221

CeraVe Baby Diaper Rash Cream

Desitin Maximum Strength Original Paste 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.

Also known as: Desitin MSOP NDC Code: 58232-0721

Desitin Maximum Strength Original Paste

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (3)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Lurie Children's Hospital Outpatient Clinic at Lincoln Park

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Dermatology CTU
• Organization: Northwestern University

NUdermatologyCTU@northwestern.edu

312-503-5944

Study Officials

• Amy Paller, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Department of Dermatology, Professor of Pediatrics

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (3)