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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colloidal Oatmeal
Topical Cream
Sponsored by
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hilltop Research
  • Hilltop Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

19306-127

19306-137

Arm Description

Experimental Topical cream applied twice daily (or as needed)

Marketed Topical cream applied twice daily (or as needed)

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)
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

Secondary Outcome Measures

Interim Eczema Area and Severity Index (EASI)
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Assessment of Itch
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Investigator's Global Atopic Dermatitis Assessment (IGADA)
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.

Full Information

First Posted
March 30, 2011
Last Updated
June 27, 2012
Sponsor
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01326910
Brief Title
Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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®

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
19306-127
Arm Type
Experimental
Arm Description
Experimental Topical cream applied twice daily (or as needed)
Arm Title
19306-137
Arm Type
Other
Arm Description
Marketed Topical cream applied twice daily (or as needed)
Intervention Type
Drug
Intervention Name(s)
Colloidal Oatmeal
Other Intervention Name(s)
Not yet marketed
Intervention Description
Topical cream applied twice daily (or as needed)
Intervention Type
Device
Intervention Name(s)
Topical Cream
Other Intervention Name(s)
EpiCeram
Intervention Description
Topical cream applied twice daily (or as needed)
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Interim Eczema Area and Severity Index (EASI)
Description
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Time Frame
Week 2
Title
Assessment of Itch
Description
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Time Frame
through Week 3
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA)
Description
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.
Time Frame
through Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Li, MD, PhD
Organizational Affiliation
Johnson & Johnson Consumer and Personal Products Worldwide
Official's Role
Study Director
Facility Information:
Facility Name
Hilltop Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Hilltop Research
City
Miamiville
State/Province
Ohio
ZIP/Postal Code
45147
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28366039
Citation
Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.
Results Reference
derived

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

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