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

• 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: Promius Pharma, LLC
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05%
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

Baseline Characteristics

Arm/Group Title		EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05%	Total
Arm/Group Description		EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05%	Total of all reporting groups
Overall Number of Baseline Participants		50	50	100
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.

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Three Item Severity Score
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

Outcome Measure Data

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%
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	EpiCeram Skin Barrier Emulsion		Desonide Cream 0.05%
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	--/--		--/--
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• 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