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

Centre Hospitalier Universitaire de Besancon4 sites in 1 country10 target enrollmentJune 2011

ConditionsSolar Urticaria

InterventionsIntravenous immunoglobulins

DrugsIntravenous immunoglobulins

Overview

Phase: Phase 2
Intervention: Intravenous immunoglobulins
Conditions: Solar Urticaria
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 10
Locations: 4
Primary Endpoint: Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•social insurance
•signed informed consent
•solar urticaria (SU) confirmed with photoexplorations
•SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
•SU with altered quality of life
•SU resistant to photoprotection
•SU resistant to the association of two different antihistaminics during 3 months

Exclusion Criteria

•Pregnancy
•Heat triggered urticaria
•Contra-indications to IVIG

Arms & Interventions

Intravenous immunoglobulins

Intervention: Intravenous immunoglobulins

Outcomes

Primary Outcomes

Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Time Frame: 3 months

Secondary Outcomes

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)
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)