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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Saint-Louis Hospital, Paris, France | OTHER |
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Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous immunoglobulins | Experimental | Intravenous immunoglobulins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous immunoglobulins | Drug | Single administration of 2 g/kg intravenous immunoglobulins over 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 1 month | |
| Percentage of patients obtaining 1 month after treatment an improvement of quality of life | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Aubin, Pr | University Hospital of Besançon | Principal Investigator |
| Manuelle Viguier, Dr | Saint-Louis Hospital, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional University Hospital | Besançon | 25000 | France | |||
| University Hospital |
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| ID | Term |
|---|---|
| D000092130 | Urticaria, Solar |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000094482 | Chronic Inducible Urticaria |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Percentage of patients obtaining after 1 month of treatment a complete clinical response | 1 month |
| Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity | 1 month |
| Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 6 months |
| Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 12 months |
| Percentage of patients obtaining 3 months after treatment an improvement of quality of life | 3 months |
| Percentage of patients obtaining 6 months after treatment an improvement of quality of life | 6 months |
| Percentage of patients obtaining 12 months after treatment an improvement of quality of life | 12 months |
| Percentage of patients obtaining after 3 months of treatment a complete clinical response | 3 months |
| Percentage of patients obtaining after 6 months of treatment a complete clinical response | 6 months |
| Percentage of patients obtaining after 12 months of treatment a complete clinical response | 12 months |
| Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity | 3 months |
| Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity | 6 months |
| Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity | 12 months |
| Caen |
| 14033 |
| France |
| University Hospital | Grenoble | 38043 | France |
| Regional University Hospital | Lille | 59037 | France |
| University hospital | Limoges | 87042 | France |
| Regional University Hospital | Montpellier | 34295 | France |
| University Hospital | Nancy | 54035 | France |
| University Hospital | Nîmes | 30029 | France |
| Saint louis Hospital | Paris | 75475 | France |
| University Hospital | Reims | 51092 | France |
| University Hospital | Rennes | 35033 | France |
| University Hospital | Toulouse | 31059 | France |
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |