Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
- Conditions
- Solar Urticaria
- Interventions
- Drug: Intravenous immunoglobulins
- Registration Number
- NCT01360658
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- Pregnancy
- Heat triggered urticaria
- Contra-indications to IVIG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravenous immunoglobulins Intravenous immunoglobulins Intravenous immunoglobulins
- Primary Outcome Measures
Name Time Method Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose 3 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
University hospital
🇫🇷Limoges, France
University Hospital
🇫🇷Toulouse, France
Regional University Hospital
🇫🇷Montpellier, France
Saint louis Hospital
🇫🇷Paris, France