To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children - Full Text View

Purpose

The purpose of this study is 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 is being done to see how safe the investigational new study product is and how well it will work to treat AD in children, by making AD visually better, and reducing the amount of itch.

Condition	Intervention
Atopic Dermatitis	Device: F# 11054-010 Device: F# 10495-053

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Eczema

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:

EASI score [ Time Frame: at Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

EASI score [ Time Frame: at Day 15 ] [ Designated as safety issue: No ]
IGADA of therapy [ Time Frame: at Day 43 ] [ Designated as safety issue: No ]
Subject's and/or caregiver's assessment of itch, on a 10-cm VAS [ Time Frame: at Day 43 ] [ Designated as safety issue: No ]

Enrollment:	108
Study Start Date:	April 2009
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 11054-010 F# 11054-010 Investigational Device	Device: F# 11054-010 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. Other Name: Investigational Device
Active Comparator: 10495-053 F# 10495-053 Atopiclair	Device: F# 10495-053 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. Other Name: Atopiclair® Skin and Wound Emulsion

Detailed Description:

This is 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 will be screened to ensure that approximately 80 subjects are randomized, to yield 70 completed subjects. Subjects will be randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects will 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 will be used topically during the duration of the study.

Eligibility

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (See Topical Corticosteroid Potency Chart in Section 5.6). 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886587

Locations

United States, Colorado
Thomas J. Stephens & Associates, Inc
Colorado Springs, Colorado, United States, 80915
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

Study Director:

Qing Li, PhD

Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.

More Information

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00886587 History of Changes
Other Study ID Numbers:	EMOECZ0002
Study First Received:	April 22, 2009
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

eczema

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013