Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Solar Urticaria Clinical Trial

— IGUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360658
• Other study ID #: N/2010/57
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2011
• Last updated: July 29, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solar Urticaria
• Urticaria

Intervention

Drug:
• Intravenous immunoglobulins
Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Locations

Country	Name	City	State
France	Regional University Hospital	Besançon
France	University Hospital	Caen
France	University Hospital	Grenoble
France	Regional University Hospital	Lille
France	University hospital	Limoges
France	Regional University Hospital	Montpellier
France	University Hospital	Nancy
France	University Hospital	Nîmes
France	Saint louis Hospital	Paris
France	University Hospital	Reims
France	University Hospital	Rennes
France	University Hospital	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Ministry of Health, France, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose		3 months	No
Secondary	Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose		1 month	No
Secondary	Percentage of patients obtaining 1 month after treatment an improvement of quality of life		1 month	No
Secondary	Percentage of patients obtaining after 1 month of treatment a complete clinical response		1 month	No
Secondary	Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity		1 month	No
Secondary	Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose		6 months	No
Secondary	Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose		12 months	No
Secondary	Percentage of patients obtaining 3 months after treatment an improvement of quality of life		3 months	No
Secondary	Percentage of patients obtaining 6 months after treatment an improvement of quality of life		6 months	No
Secondary	Percentage of patients obtaining 12 months after treatment an improvement of quality of life		12 months	No
Secondary	Percentage of patients obtaining after 3 months of treatment a complete clinical response		3 months	No
Secondary	Percentage of patients obtaining after 6 months of treatment a complete clinical response		6 months	No
Secondary	Percentage of patients obtaining after 12 months of treatment a complete clinical response		12 months	No
Secondary	Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity		3 months	No
Secondary	Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity		6 months	No
Secondary	Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity		12 months	No