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Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier:
NCT01326910
First received: March 30, 2011
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
Results First Received: June 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Colloidal Oatmeal
Device: Topical Cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
19306-127 Experimental Topical cream applied twice daily (or as needed)
19306-137 Marketed Topical cream applied twice daily (or as needed)

Participant Flow:   Overall Study
    19306-127     19306-137  
STARTED     45     45  
COMPLETED     41     42  
NOT COMPLETED     4     3  
Withdrawal by Subject                 3                 2  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
19306-127 Experimental Topical cream applied twice daily (or as needed)
19306-137 Marketed Topical cream applied twice daily (or as needed)
Total Total of all reporting groups

Baseline Measures
    19306-127     19306-137     Total  
Number of Participants  
[units: participants]
 		  45     45     90  
Age  
[units: years]
Mean ± Standard Deviation 		  6.9  ± 3.26     9.3  ± 4.26     8.1  ± 3.96  
Gender  
[units: participants]
 		     
Female     23     26     49  
Male     22     19     41  
Region of Enrollment  
[units: participants]
 		     
United States     45     45     90  



  Outcome Measures
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1.  Primary:   Eczema Area and Severity Index (EASI)   [ Time Frame: 3 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Interim Eczema Area and Severity Index (EASI)   [ Time Frame: Week 2 ]
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3.  Secondary:   Assessment of Itch   [ Time Frame: through Week 3 ]
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4.  Secondary:   Investigator's Global Atopic Dermatitis Assessment (IGADA)   [ Time Frame: through Week 3 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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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Results Point of Contact:  
Name/Title: Joyce Hauze, Sr. Specialist Clinical Quality Systems and Process
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com


No publications provided


Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier: NCT01326910     History of Changes
Other Study ID Numbers: COOADM3002, HTR 11-130435-111
Study First Received: March 30, 2011
Results First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board