Back to resultsTo Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F# 11054-010
F# 10495-053
Sponsored by
About this trial
This is an interventional basic science trial for Atopic Dermatitis focused on measuring eczema
Eligibility Criteria
Inclusion Criteria:
- Post-menarchal female subjects must have a negative urine pregnancy test
- Willing to provide written informed consent/assent
- Diagnosed as having mild to moderate Atopic Dermatitis (AD)
- Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
- Willing to replace their body wash and/or soaps with the one provided in this trial
Exclusion Criteria:
- Severe AD as determined by the Rajka-Langeland Severity Index
- AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
- History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
- Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
- Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
Sites / Locations
- Thomas J. Stephens & Associates, Inc
- Academic Dermatology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
11054-010
10495-053
Arm Description
F# 11054-010 Investigational Device
F# 10495-053 Atopiclair
Outcomes
Primary Outcome Measures
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Secondary Outcome Measures
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Itch Score on Day 43 - Change From Baseline
The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.
Full Information
NCT ID
NCT00886587
First Posted
April 22, 2009
Last Updated
April 24, 2017
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
1. Study Identification
Unique Protocol Identification Number
NCT00886587
Brief Title
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Official Title
A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.
Detailed Description
This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.
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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11054-010
Arm Type
Experimental
Arm Description
F# 11054-010 Investigational Device
Arm Title
10495-053
Arm Type
Active Comparator
Arm Description
F# 10495-053 Atopiclair
Intervention Type
Device
Intervention Name(s)
F# 11054-010
Other Intervention Name(s)
Investigational Device
Intervention Description
Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
Intervention Type
Device
Intervention Name(s)
F# 10495-053
Other Intervention Name(s)
Atopiclair® Skin and Wound Emulsion
Intervention Description
Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
Description
The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Time Frame
Baseline to Day 43
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
Description
The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Time Frame
Baseline to Day 15
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
Description
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Time Frame
Baseline to Day 43
Title
Itch Score on Day 43 - Change From Baseline
Description
The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.
Time Frame
Baseline to Day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menarchal female subjects must have a negative urine pregnancy test
Willing to provide written informed consent/assent
Diagnosed as having mild to moderate Atopic Dermatitis (AD)
Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
Willing to replace their body wash and/or soaps with the one provided in this trial
Exclusion Criteria:
Severe AD as determined by the Rajka-Langeland Severity Index
AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Li, PhD
Organizational Affiliation
Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Thomas J. Stephens & Associates, Inc
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
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