Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

June 27, 2012 updated by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children

This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St Petersburg, Florida, United States, 33710
        • Hilltop Research
    • Ohio
      • Miamiville, Ohio, United States, 45147
        • Hilltop Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 6 mo- 18 years
  • Any ethnicity
  • Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
  • Mild to moderate atopic dermatitis per Rajka-Langeland severity index
  • Willing to use only provided cream and body wash for duration of study

Exclusion Criteria:

  • Known sensitivity to investigational products
  • Pregnant or breastfeeding
  • Severe AD per Rajka-Langeland severity index
  • AD requiring class I (super potent) or class II or III (potent) topical steroids
  • Requires greater than 2.0 g inhaled or intranasal corticosteroids
  • Other skin conditions which may interfere with the scoring of AD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 19306-127
Experimental Topical cream applied twice daily (or as needed)
Drug: Colloidal Oatmeal
Topical cream applied twice daily (or as needed)
Other Names:
  • Not yet marketed
Other: 19306-137
Marketed Topical cream applied twice daily (or as needed)
Device: Topical Cream
Topical cream applied twice daily (or as needed)
Other Names:
  • EpiCeram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: 3 weeks
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interim Eczema Area and Severity Index (EASI)
Time Frame: Week 2
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Week 2
Assessment of Itch
Time Frame: through Week 3
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
through Week 3
Investigator's Global Atopic Dermatitis Assessment (IGADA)
Time Frame: through Week 3
An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.
through Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Investigators

  • Study Director: Qing Li, MD, PhD, Johnson & Johnson Consumer and Personal Products Worldwide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COOADM3002
  • HTR 11-130435-111 (Other Identifier: CRO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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