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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00886587
First received: April 22, 2009
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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:


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

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline [ Time Frame: Baseline to Day 43 ]
    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 [ Time Frame: Baseline to Day 15 ]
    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 [ Time Frame: Baseline to Day 43 ]
    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 [ Time Frame: Baseline to Day 43 ]
    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.


Enrollment: 82
Study Start Date: April 2009
Study Completion Date: June 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 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.
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: January 16, 2017
Last Updated: April 24, 2017

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017