Trial Outcomes & Findings for Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis (NCT NCT00828412)

Last Updated: 2017-01-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2017-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	EpiCeram Skin Barrier Emulsion EpiCeram Skin Barrier Emulsion topically twice daily	Desonide Cream 0.05% Desonide Cream 0.05% topically twice daily
Overall Study STARTED	50	50
Overall Study COMPLETED	41	48
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EpiCeram Skin Barrier Emulsion n=50 Participants EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05% n=50 Participants Desonide Cream 0.05%	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	4.8 years STANDARD_DEVIATION 3.3 • n=7 Participants	5.2 years STANDARD_DEVIATION 3.4 • n=5 Participants
Gender Female	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Gender Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Three item severity score	5.4 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants	5.5 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	5.5 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

Population: All subjects with data were included in the analysis. No imputation was done for missing data.

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

Outcome measures
Measure	EpiCeram Skin Barrier Emulsion n=41 Participants Week 6 EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05% n=48 Participants Week 6 Desonide Cream 0.05%
Change From Baseline in Three Item Severity Score	-2.6 units on a scale Standard Deviation 2.0	-3.6 units on a scale Standard Deviation 1.8

Adverse Events

EpiCeram Skin Barrier Emulsion

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Desonide Cream 0.05%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EpiCeram Skin Barrier Emulsion n=50 participants at risk EpiCeram Skin Barrier Emulsion	Desonide Cream 0.05% n=50 participants at risk Desonide Cream 0.05%
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.0% 1/50 • Number of events 1	6.0% 3/50 • Number of events 3
Skin and subcutaneous tissue disorders Dernatitis atopic	12.0% 6/50 • Number of events 6	0.00% 0/50

Additional Information

Joanne Fraser

Promius Pharma

Phone: 908 429-4504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place