Atopic Dermatitis
Conditions
Brief summary
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
Interventions
topical cream, twice daily, 6 weeks
DRUGDesonide Cream 0.05%
topical cream, twice daily, 6 weeks
Sponsors
Promius Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* at least 3 months of age and less than 13 years of age * atopic dermatitis of moderate severity
Exclusion criteria
* pregnant or lactating * treatment of atopic dermatitis with topical product in the 14 days prior to Baseline * treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline * serious or uncontrolled medical condition * active infection * significant use of inhaled, intranasal, or intraocular corticosteroid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Three Item Severity Score | Baseline to 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EpiCeram Skin Barrier Emulsion EpiCeram Skin Barrier Emulsion | 50 |
| Desonide Cream 0.05% Desonide Cream 0.05% | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | EpiCeram Skin Barrier Emulsion | Desonide Cream 0.05% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.5 years STANDARD_DEVIATION 3.5 | 4.8 years STANDARD_DEVIATION 3.3 | 5.2 years STANDARD_DEVIATION 3.4 |
| Gender Female | 25 Participants | 30 Participants | 55 Participants |
| Gender Male | 25 Participants | 20 Participants | 45 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Three item severity score | 5.4 units on a scale STANDARD_DEVIATION 0.7 | 5.5 units on a scale STANDARD_DEVIATION 0.7 | 5.5 units on a scale STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 50 | 3 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change From Baseline in Three Item Severity Score
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
Population: All subjects with data were included in the analysis. No imputation was done for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Three Item Severity Score | -2.6 units on a scale | Standard Deviation 2 |
| Desonide Cream 0.05% | Change From Baseline in Three Item Severity Score | -3.6 units on a scale | Standard Deviation 1.8 |