Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT00828412 |
Recruitment Status :
Completed
First Posted : January 26, 2009
Results First Posted : December 9, 2013
Last Update Posted : January 30, 2017
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Sponsor:
Promius Pharma, LLC
Information provided by (Responsible Party):
Promius Pharma, LLC
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | EpiCeram Skin Barrier Emulsion | Desonide Cream 0.05% |
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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 |
Baseline Characteristics
Arm/Group Title | EpiCeram Skin Barrier Emulsion | Desonide Cream 0.05% | Total | |
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EpiCeram Skin Barrier Emulsion | Desonide Cream 0.05% | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 50 | 100 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 50 participants | 100 participants | |
<=18 years |
50 100.0%
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50 100.0%
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100 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 50 participants | 50 participants | 100 participants | |
Female |
25 50.0%
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30 60.0%
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55 55.0%
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Male |
25 50.0%
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20 40.0%
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45 45.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Joanne Fraser |
Organization: | Promius Pharma |
Phone: | 908 429-4504 |
EMail: | joannefraser@promiuspharma.com |
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 |