Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Condition(s) targeted: Solar Urticaria

Intervention: Intravenous immunoglobulins (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Besancon

Official(s) and/or principal investigator(s):
François Aubin, Pr, Principal Investigator, Affiliation: University Hospital of Besançon
Manuelle Viguier, Dr, Principal Investigator, Affiliation: Saint-Louis Hospital, Paris, France

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.

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

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

Primary outcome: Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Secondary outcome:

Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Percentage of patients obtaining 1 month after treatment an improvement of quality of life

Percentage of patients obtaining after 1 month of treatment a complete clinical response

Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity

Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Percentage of patients obtaining 3 months after treatment an improvement of quality of life

Percentage of patients obtaining 6 months after treatment an improvement of quality of life

Percentage of patients obtaining 12 months after treatment an improvement of quality of life

Percentage of patients obtaining after 3 months of treatment a complete clinical response

Percentage of patients obtaining after 6 months of treatment a complete clinical response

Percentage of patients obtaining after 12 months of treatment a complete clinical response

Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity

Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity

Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Regional University Hospital, Besançon 25000, France

University Hospital, Caen 14033, France

University Hospital, Grenoble 38043, France

Regional University Hospital, Lille 59037, France

University hospital, Limoges 87042, France

Regional University Hospital, Montpellier 34295, France

University Hospital, Nancy 54035, France

University Hospital, Nîmes 30029, France

Saint louis Hospital, Paris 75475, France

University Hospital, Reims 51092, France

University Hospital, Rennes 35033, France

University Hospital, Toulouse 31059, France

Starting date: June 2011
Last updated: July 29, 2013