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The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.
The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.
Adherence will be measured by MEMs cap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cream- | Active Comparator | topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis |
|
| Ointment | Active Comparator | topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis |
|
| Lipocream | Active Comparator | topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone 17-butyrate 0.1% Cream preparation | Drug | Apply medication twice a day to affected areas of atopic dermatitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Locoid | Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Feldman, MD, PhD | 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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Participants were recruited from IRB approved advertising and the Dermatology Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ointment | topical hydrocortisone 17-butyrate 0.1% preparation ointment |
| FG001 | Lipocream | topical hydrocortisone 17-butyrate 0.1% preparation lipocream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| hydrocortisone 17-butyrate 0.1% Ointment preparation | Drug | Apply medication twice a day to affected areas of atopic dermatitis |
|
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| hydrocortisone 17-butyrate 0.1% Lipocream preparation | Drug | Apply medication twice a day to affected areas of atopic dermatitis |
|
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| FG002 | Cream | topical hydrocortisone 17-butyrate 0.1% preparation cream |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cream | topical hydrocortisone 17-butyrate 0.1% cream applied twice daily |
| BG001 | Ointment | topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily |
| BG002 | Lipocream | topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 to Locoid | Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied | Posted | Mean | Standard Deviation | percentage of days | 2 weeks |
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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 Hydrocortisone 17-butyrate 0.1% Cream | topical hydrocortisone 17-butyrate 0.1% cream applied twice daily | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Topical Hydrocortisone 17-butyrate 0.1% Ointment | topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Topical Hydrocortisone 17-butyrate 0.1% Lipocream | topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest University Health Sciences | 336-716-3775 | sfeldman@wfubmc.edu |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C007975 | hydrocortisone-17-butyrate |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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