Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 2

Conditions: Solar Urticaria

Treatments: Drug: Intravenous immunoglobulins

Study type: Interventional

Funder types: Other

Identifiers

NCT01360658

N/2010/57

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intravenous immunoglobulins

Experimental group

Description:

Intravenous immunoglobulins

Treatment:

Drug: Intravenous immunoglobulins