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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus.
This is a 20 week, single center, open-label pilot study to enroll 5 subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efalizumab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| primary efficacy measure will be oral mucosal surface area involvement | area of oral mucosa involvement was measured in cm2 at baseline, week 4, week 8, week 12 and week 20. the primary efficacy outcome measure was the change in oral mucosal involvement at week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| clinical lesion score | a numerical score from 0 to 5 where 0 = no lesion; 1 = white striae only; 2 = white striae and erosion < 1 cm; 3 = white striae and erosion > 1 cm; 4 = white striae and ulceration < 1 cm; 5 = white striae and ulceration > 1 cm | Week 0, 1, 4, 8, 12, and 20 |
| ten centimeter visual analogue pain scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P. Heffernan, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| C472181 | efalizumab |
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Patients were asked to put an X on a 10 cm line that corresponded to their degree of pain where 0 cm represented no pain and 10 cm represented the most severe pain |
| Week 0, 1, 4, 8, 12, and 20 |
| oral health impact profile-14 questionnaire | The OHIP-14 is a validated measure of the negative impact of oral disease on an individual's well being. The impact of various oral problems are rated from "never" to "very often," which correlates to a score of 0 to 4. The responses are weighted and summated giving a maximum score of 56 and a minimum score of 0. | Week 0, 1, 4, 8, 12, and 20 |
| cutaneous surface area involvement | The area of cutaneous disease involvement was measured in cm2 | Week 0, 1, 4, 8, 12, and 20 |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |