Solar Urticaria
Conditions
Keywords
Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, Safety
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.
Interventions
Single administration of 2 g/kg intravenous immunoglobulins over 2 days
Sponsors
Ministry of Health, France
Saint-Louis Hospital, Paris, France
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose | 1 month |
| 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 |
| Percentage of patients obtaining 12 months after treatment an improvement of quality of life | 12 months |
Countries
France
Outcome results
None listed