NCT01360658

Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solar Urticaria

Interventions

Type	Name	Description
DRUG	Intravenous immunoglobulins	Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-05-25
• Last updated: 2013-07-30

Locations

12 sites across 1 country: France