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Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

NCT01360658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-07-30

No results posted yet for this study

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

DRUG

Intravenous immunoglobulins

Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Saint-Louis Hospital, Paris, France

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • François Aubin, Pr · University Hospital of Besançon

  • Manuelle Viguier, Dr · Saint-Louis Hospital, Paris, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360658 on ClinicalTrials.gov