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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A screening and baseline clinic visit will be required for each patient enrolled in the study. Each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. One morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. Patients will be asked about side effects (local and systemic). Patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imiquimod 5% cream (Aldara) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score. |
| Measure | Description | Time Frame |
|---|---|---|
| Any adverse outcome is recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene T Dytoc, MD PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Marlene Dytoc's clinic | Edmonton | Alberta | T6G 2C8 | Canada | ||
| University of Alberta |
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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 |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Edmonton |
| Alberta |
| T6G 2G3 |
| Canada |
| Dr. Loretta Fiorillo's clinic | Red Deer | Alberta | T4N 6R2 | Canada |
| D006571 | Heterocyclic Compounds |