Clinical trial NCT01360658: Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
Official title: Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solar Urticaria
Keywords: Intravenous immunoglobulins
Solar urticaria
Minimal urticaria dose
Quality of life
Safety
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Saint-Louis Hospital, Paris, France
First posted: 2011-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
timeFrame: 1 month
measure: Percentage of patients obtaining 1 month after treatment an improvement of quality of life
timeFrame: 1 month
measure: Percentage of patients obtaining after 1 month of treatment a complete clinical response
timeFrame: 1 month
measure: Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity
timeFrame: 1 month
measure: Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
timeFrame: 6 months
measure: Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
timeFrame: 12 months
measure: Percentage of patients obtaining 3 months after treatment an improvement of quality of life
timeFrame: 3 months
measure: Percentage of patients obtaining 6 months after treatment an improvement of quality of life
timeFrame: 6 months
measure: Percentage of patients obtaining 12 months after treatment an improvement of quality of life
timeFrame: 12 months
measure: Percentage of patients obtaining after 3 months of treatment a complete clinical response
timeFrame: 3 months
measure: Percentage of patients obtaining after 6 months of treatment a complete clinical response
timeFrame: 6 months
measure: Percentage of patients obtaining after 12 months of treatment a complete clinical response
timeFrame: 12 months
measure: Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity
timeFrame: 3 months
measure: Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity
timeFrame: 6 months
measure: Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity
timeFrame: 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Regional University Hospital
city: Caen
country: France
facility: University Hospital
city: Grenoble
country: France
facility: University Hospital
city: Lille
country: France
facility: Regional University Hospital
city: Limoges
country: France
facility: University hospital
city: Montpellier
country: France
facility: Regional University Hospital
city: Nancy
country: France
facility: University Hospital
city: Nîmes
country: France
facility: University Hospital
city: Paris
country: France
facility: Saint louis Hospital
city: Reims
country: France
facility: University Hospital
city: Rennes
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital of Besançon
name: François Aubin, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint-Louis Hospital, Paris, France
name: Manuelle Viguier, Dr
role: PRINCIPAL_INVESTIGATOR
References: