Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Business Reasons
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
The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
Treatment medication will be administered topically twice daily for 28 days
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product 0405 | Experimental | Topical active investigational Product 0405 |
|
| Placebo for Product 0405 | Placebo Comparator | Topical Placebo for Product 0405 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product 0405 | Drug | Product 0405 will be administered topically twice daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant superiority of the test Product 0405 to the vehicle | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment. | 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Angela C Kaplan | Fougera Pharmaceuticals Inc. | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo for Product 0405 |
| Drug |
Placebo for Product 0405 will be administered topically twice daily for 28 days. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |