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| ID | Type | Description | Link |
|---|---|---|---|
| 32426 |
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The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.
To assess the efficacy of a desonide hydrogel 0.05% in both young children (age <13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical desonide hydrogel 0.05% | Experimental | Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical desonide hydrogel 0.05% | Drug | apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment at Week 4 | The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Feldman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Desonide Hydrogel 0.05% | Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Desonide Hydrogel 0.05% | Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Global Assessment at Week 4 | The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Desonide Hydrogel 0.05% | Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Steve feldman | Wake Forest University Health Sciences | 336-716-3775 | sfeldman@wakehealth.edu |
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| 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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| 0 |
| 41 |
| 0 |
| 41 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |