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This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical calcipotriene 0.005% ointment | Other | Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical calcipotriene 0.005% ointment | Drug | Affected area will be treated twice daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Gene Expression From Skin Biopsy | Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels | day 0 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of life questions will be asked at day 0 and 3 months | day 0 and 3 months |
| Modified Localized Scleroderma Skin Score | The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Calcipotriene 0.005% Ointment | Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Calcipotriene 0.005% Ointment | Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months |
| 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 | Change of Gene Expression From Skin Biopsy | Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels | Study was terminated prior to obtaining results. | Posted | day 0 and 3 months |
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|
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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 Calcipotriene 0.005% Ointment | Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Rangel | Northwestern University | 3125035942 | stephanie.rangel@northwestern.edu |
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| ID | Term |
|---|---|
| D012594 | Scleroderma, Localized |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| day 0 and 3 months |
| Change of Appearance of Skin Biopsy | Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins | day 0 and 3 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Secondary | Quality of Life | Quality of life questions will be asked at day 0 and 3 months | Study was terminated prior to obtaining results. | Posted | day 0 and 3 months |
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| Secondary | Modified Localized Scleroderma Skin Score | The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months | Study was terminated before results were obtained. | Posted | day 0 and 3 months |
|
|
| Secondary | Change of Appearance of Skin Biopsy | Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins | Study was terminated before results were obtained. | Posted | day 0 and 3 months |
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| 0 |
| 2 |
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