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

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

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.

1.  Primary:

Change From Baseline in Three Item Severity Score   [ Time Frame: Baseline to 6 weeks ]

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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