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Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828412
First Posted: January 26, 2009
Last Update Posted: January 30, 2017
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.
Information provided by (Responsible Party):
Promius Pharma, LLC
Results First Submitted: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Device: EpiCeram Skin Barrier Emulsion
Drug: Desonide Cream 0.05%

  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
No text entered.

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
EpiCeram Skin Barrier Emulsion EpiCeram Skin Barrier Emulsion topically twice daily
Desonide Cream 0.05% Desonide Cream 0.05% topically twice daily

Participant Flow:   Overall Study
    EpiCeram Skin Barrier Emulsion   Desonide Cream 0.05%
STARTED   50   50 
COMPLETED   41   48 
NOT COMPLETED   9   2 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
EpiCeram Skin Barrier Emulsion EpiCeram Skin Barrier Emulsion
Desonide Cream 0.05% Desonide Cream 0.05%
Total Total of all reporting groups

Baseline Measures
   EpiCeram Skin Barrier Emulsion   Desonide Cream 0.05%   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 50   50   100 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      50 100.0%      50 100.0%      100 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 5.5  (3.5)   4.8  (3.3)   5.2  (3.4) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      25  50.0%      30  60.0%      55  55.0% 
Male      25  50.0%      20  40.0%      45  45.0% 
Region of Enrollment 
[Units: Participants]
 		     
United States   50   50   100 
Three item severity score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 5.4  (0.7)   5.5  (0.7)   5.5  (0.7) 
[1] The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.


  Outcome Measures

1.  Primary:   Change From Baseline in Three Item Severity Score   [ Time Frame: Baseline to 6 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Joanne Fraser
Organization: Promius Pharma
phone: 908 429-4504
e-mail: joannefraser@promiuspharma.com



Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT00828412     History of Changes
Other Study ID Numbers: EPC0801
First Submitted: January 21, 2009
First Posted: January 26, 2009
Results First Submitted: September 17, 2013
Results First Posted: December 9, 2013
Last Update Posted: January 30, 2017



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