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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC
ClinicalTrials.gov Identifier:
NCT00828412
First received: January 21, 2009
Last updated: December 1, 2016
Last verified: December 2016
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  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
Study First Received: January 21, 2009
Results First Received: September 17, 2013
Last Updated: December 1, 2016