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

NCT ID: NCT00886587

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-06-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

11054-010

F# 11054-010 Investigational Device

Group Type: EXPERIMENTAL

F# 11054-010

Intervention Type: DEVICE

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.

10495-053

F# 10495-053 Atopiclair

Group Type: ACTIVE_COMPARATOR

F# 10495-053

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Investigational Device; Atopiclair® Skin and Wound Emulsion

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Li, PhD

Role: STUDY_DIRECTOR

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

Locations

Thomas J. Stephens & Associates, Inc

Colorado Springs, Colorado, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

EMOECZ0002

Identifier Type: -

Identifier Source: org_study_id