Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00828412
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : December 9, 2013
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

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%
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Hide Arm/Group Description EpiCeram Skin Barrier Emulsion topically twice daily Desonide Cream 0.05% topically twice daily
Period Title: Overall Study
Started 50 50
Completed 41 48
Not Completed 9 2
Arm/Group Title EpiCeram Skin Barrier Emulsion Desonide Cream 0.05% Total
Hide Arm/Group Description EpiCeram Skin Barrier Emulsion Desonide Cream 0.05% Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
5.5  (3.5) 4.8  (3.3) 5.2  (3.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
25
  50.0%
30
  60.0%
55
  55.0%
Male
25
  50.0%
20
  40.0%
45
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
Three item severity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
5.4  (0.7) 5.5  (0.7) 5.5  (0.7)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in Three Item Severity Score
Hide Description 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.
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with data were included in the analysis. No imputation was done for missing data.
Arm/Group Title EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Hide Arm/Group Description:
Week 6 EpiCeram Skin Barrier Emulsion
Week 6 Desonide Cream 0.05%
Overall Number of Participants Analyzed 41 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.6  (2.0) -3.6  (1.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Hide Arm/Group Description EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
All-Cause Mortality
EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
EpiCeram Skin Barrier Emulsion Desonide Cream 0.05%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/50 (14.00%)      3/50 (6.00%)    
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  1/50 (2.00%)  1 3/50 (6.00%)  3
Skin and subcutaneous tissue disorders     
Dernatitis atopic  6/50 (12.00%)  6 0/50 (0.00%)  0
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
Layout table for Results Point of Contact information
Name/Title: Joanne Fraser
Organization: Promius Pharma
Phone: 908 429-4504
EMail: joannefraser@promiuspharma.com
Layout table for additonal information
Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT00828412    
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