Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Condition(s) targeted: Solar Urticaria

Intervention: Intravenous immunoglobulins (Drug)

Phase: Phase 2

Status: Recruiting

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

Overall contact:
Stéphanie François, Ing, Phone: 3 81 21 89 88, Ext: 0033, Email: sfrancois@chu-besancon.fr

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

Stéphanie François, Ing, Phone: 3 81 21 89 88, Ext: 0033, Email: sfrancois@chu-besancon.fr

Regional University Hospital, Besançon 25000, France; Recruiting
François Aubin, Pr, Phone: 3 81 21 84 83, Ext: 0033, Email: faubin@chu-besancon.fr
François Aubin, Pr, Principal Investigator

University Hospital, Caen 14033, France; Recruiting
Dominique Leroy, Pr, Phone: 2 21 27 25 06, Ext: 0033, Email: leroy-d@chu-caen.fr
Anne Moreau, Dr, Phone: 2 21 27 25 06, Ext: 0033
Dominique Leroy, Pr, Principal Investigator
Anne Moreau, Dr, Sub-Investigator

University Hospital, Grenoble 38043, France; Not yet recruiting
Jean Claude Béani, Pr, Phone: 4 76 76 55 56, Ext: 0033, Email: jcbeani@chu-grenoble.fr
Jean-Luc Bourrain, Phone: 4 76 76 55 58, Ext: 0033, Email: jlbourrain@chu-grenoble.fr
Jean Claude Béani, Pr, Principal Investigator
Jean Luc Bourrain, Dr, Sub-Investigator

Regional University Hospital, Lille 59037, France; Not yet recruiting
Pierre Thomas, Pr, Phone: 3 20 44 43 01, Ext: 0033, Email: pierre1.thomas@chru-lille.fr
Annie Bonnevalle, Dr, Phone: 3 20 44 54 34, Ext: 0033, Email: annie.bonnevalle@chru-lille.fr
Pierre Thomas, Pr, Principal Investigator
Annie Bonnevalle, Dr, Sub-Investigator
Emmanuel Delaporte, Pr, Sub-Investigator

University hospital, Limoges 87042, France; Recruiting
Christophe Bedane, Pr, Phone: 5 55 05 64 30, Ext: 0033, Email: christophe.bedane@chu-limoges.fr
Christophe Bedane, Pr, Principal Investigator

Regional University Hospital, Montpellier 34295, France; Not yet recruiting
Aurélie Du-Thanh, Dr, Phone: 4 67 33 69 06, Ext: 0033, Email: a-du_thanh@chu-montpellier.fr
Jean Louis Peyron, Dr, Phone: 4 67 33 69 09, Ext: 0033, Email: jl-peyron@chu-montpellier.fr
Aurélie Du-Thanh, Dr, Principal Investigator
Jean Louis Peyron, Dr, Sub-Investigator

University Hospital, Nancy 54035, France; Not yet recruiting
Jean Luc Schmutz, Pr, Phone: 3 83 85 24 66, Ext: 0033, Email: jl.schmutz@chu-nancy.fr
Françoise Chastel, Dr, Phone: 3 83 85 24 66, Ext: 0033

University Hospital, Nîmes 30029, France; Not yet recruiting
Laurent Meunier, Pr, Phone: 4 66 68 31 71, Ext: 0033, Email: laurent.meunier@chu-nimes.fr
Pierre Emmanuel Stoebner, Dr, Phone: 4 66 68 31 71, Ext: 0033, Email: pierre.stoebner@chu-nimes.fr
Laurent Meunier, Pr, Principal Investigator
Pierre Emmanuel Stoebner, Dr, Sub-Investigator

Saint louis Hospital, Paris 75475, France; Not yet recruiting
Manuelle Viguier, Dr, Phone: 1 42 49 98 43, Ext: 0033, Email: manuelle.viguier@sls.aphp.fr
Michel Jeanmougin, Dr, Phone: 1 42 49 95 92, Ext: 0033, Email: michel.jeanmougin@sls.aphp.fr
Manuelle Viguier, Dr, Principal Investigator
Michel Jeanmougin, Dr, Sub-Investigator

University Hospital, Reims 51092, France; Recruiting
Philippe Bernard, Pr, Phone: 3 26 78 43 68, Ext: 0033, Email: pbernard@chu-reims.fr
Fabienne Leonard, Dr, Phone: 3 26 78 43 67, Ext: 0033
Philippe Bernard, Pr, Principal Investigator
Fabienne Leonard, Dr, Sub-Investigator

University Hospital, Rennes 35033, France; Not yet recruiting
Alain Dupuy, Pr, Phone: 2 99 28 41 00, Ext: 0033, Email: alain.dupuy@chu-rennes.fr
Henri Adamski, Dr, Phone: 2 99 28 43 49, Ext: 0033, Email: henri.adamski@chu-rennes.fr
Alain Dupuy, Pr, Principal Investigator
Henri Adamski, Dr, Sub-Investigator
Monica Dinulescu, Dr, Sub-Investigator

University Hospital, Toulouse 31059, France; Not yet recruiting
Cristina Livideanu, Dr, Phone: 5 67 77 81 35, Ext: 0033, Email: livideanu.c@chu-toulouse.fr
Marie Claude Marguery, Dr, Phone: 5 61 77 81 42, Ext: 0033, Email: marguery.mc@chu-toulouse.fr
Cristina Livideanu, Dr, Principal Investigator
Marie Claude Marguery, Dr, Sub-Investigator

Starting date: June 2011
Last updated: September 1, 2011