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

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
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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
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.
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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 ]

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  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