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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000152-14 | EudraCT Number |
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Per protocol intermediate analyses of 76 patients and enrollment difficulties.
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T | Experimental | TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE |
|
| C | Active Comparator | TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPICAL SIROLIMUS (RAPAMUNE*) | Drug | APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| COMPLETE CLEARING OF ORAL EROSIVE LESIONS | THREE MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| REGRESSION OF EROSIVE SURFACE AREA | THREE MONTHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc VAILLANT, MD | Centre 1-TOURS | Study Director |
| Camille FRANCES, MD | Centre-2 Tenon | Principal Investigator |
| Scarlette AGBO-GODEAU, MD | Centre-3 La Pitié-Salpêtrière | Principal Investigator |
| Liliane LAROCHE, MD | Centre-4 Avicenne | Principal Investigator |
| Francis PASCAL, MD | Centre-5 St-Louis | Principal Investigator |
| Emmanuel DELAPORTE, MD | Centre-6 Lille | Principal Investigator |
| Alain TAÏEB, MD | Centre-7 Bordeaux | Principal Investigator |
| Jean-Philippe DELACOUR, MD | Centre -8 Nice | Principal Investigator |
| Philippe BERNARD, MD-PHD | Centre-9 REIMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of REIMS | Reims | Marne | F-51092 | France | ||
| Hospital Avicenne-APHP |
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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 |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| TOPICAL BETAMETHASONE 0.05% | Drug | APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months |
|
| Bobigny |
| 93009 |
| France |
| University Hospital of Bordeaux-St.André | Bordeaux | 33075 | France |
| University Hospital of Lille | Lille | 59037 | France |
| University Hospital of Nice | Nice | 06202 | France |
| Hospital Saint Louis-APHP | Paris | 75475 | France |
| Hospital La Pitié-Salpêtrière APHP | Paris | 75651 | France |
| Hospital Tenon-APHP | Paris | 75970 | France |
| University hospital of Tours | Tours | 37044 | France |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |