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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00886587
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Atopic Dermatitis
Interventions: Device: F# 11054-010
Device: F# 10495-053

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Investigational Device Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.

Participant Flow:   Overall Study
    Investigational Device   Atopiclair® Skin and Wound Emulsion
STARTED   41   41 
COMPLETED   37   39 
NOT COMPLETED   4   2 
Adverse Event                2                1 
Protocol Violation                2                0 
Withdrawal by Subject                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects.

Reporting Groups
  Description
Investigational Device Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Total Total of all reporting groups

Baseline Measures
   Investigational Device   Atopiclair® Skin and Wound Emulsion   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   41   82 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.37  (2.90)   5.56  (2.84)   5.96  (2.88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  43.9%      28  68.3%      46  56.1% 
Male      23  56.1%      13  31.7%      36  43.9% 
Region of Enrollment 
[Units: Participants]
     
United States   41   41   82 


  Outcome Measures

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

2.  Secondary:   Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline   [ Time Frame: Baseline to Day 15 ]

3.  Secondary:   Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline   [ Time Frame: Baseline to Day 43 ]

4.  Secondary:   Itch Score on Day 43 - Change From Baseline   [ Time Frame: Baseline to Day 43 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Amisha Parikh-Das, PhD/Study Director
Organization: Johnson & Johnson Consumer Inc
phone: 973 385-2863 USA EST
e-mail: AParikh1@its.jnj.com



Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00886587     History of Changes
Other Study ID Numbers: EMOECZ0002
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: January 16, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017