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| ID | Type | Description | Link |
|---|---|---|---|
| contract #32417 | Other Identifier | WakeForest |
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The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drug | Experimental | tacrolimus ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus ointment | Drug | tacrolimus ointment to be applied twice daily to affected areas during duration of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Feldman, MD, PHD | WFUHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Dermatology, WFUHS | Winston-Salem | North Carolina | 27157 | United States |
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Subjects were recruited from the Dermatology Studies Center and IRB approved advertising.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Group only had visits at Baseline and Week 4. |
| FG001 | Extra Visit Group | After Baseline, this group had an extra visit at week 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Group only had visits at Baseline and Week 4. |
| BG001 | Extra Visit Group | After Baseline, this group had an extra visit at week 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Adherence | adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed | Posted | Median | 95% Confidence Interval | percentage of required applicaitons | 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 | Control Group | Group only had visits at Baseline and Week 4. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest University Health Sciences | 336-716-3885 | sfeldman@wfubmc.edu |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Week 4 |
| EASI | Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema. | Week 4 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting." | Posted | Median | 95% Confidence Interval | % change in IGA | Week 4 |
|
|
|
| Secondary | EASI | Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Extra Visit Group | After Baseline, this group had an extra visit at week 1. | 0 | 15 | 0 | 15 | 2 | 15 |
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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 |