Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeramâ„¢ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram â„¢ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram â„¢ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cutivate(r) | Active Comparator | Topical mid-strength steroid |
|
| EpiCeram(r) | Experimental | EpiCeram(r) topical barrier repair cream. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiceram(r) | Device | Topical barrier repair emulsion cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) | 4 weeks | |
| Change in assessments of Pruritus and sleep habits | week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Sugarman, MD | University of California, San Francisco, CA | Principal Investigator |
| Lawrence Parrish, MD | Medical College of Thomas Jefferson University, Philadelphia, PA | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluticasone Propionate 0.05% |
| Drug |
Topical mid-strength steroid |
|
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |