Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01360658

First Posted: May 25, 2011

Last Update Posted: July 30, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Ministry of Health, France

Saint-Louis Hospital, Paris, France

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Besancon

Purpose

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.

Condition	Intervention	Phase
Solar Urticaria	Drug: Intravenous immunoglobulins	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria

Resource links provided by NLM:

MedlinePlus related topics: Hives

Drug Information available for: Rhophylac

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:

Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 3 months ]

Secondary Outcome Measures:

Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 1 month ]
Percentage of patients obtaining 1 month after treatment an improvement of quality of life [ Time Frame: 1 month ]
Percentage of patients obtaining after 1 month of treatment a complete clinical response [ Time Frame: 1 month ]
Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 1 month ]
Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 6 months ]
Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 12 months ]
Percentage of patients obtaining 3 months after treatment an improvement of quality of life [ Time Frame: 3 months ]
Percentage of patients obtaining 6 months after treatment an improvement of quality of life [ Time Frame: 6 months ]
Percentage of patients obtaining 12 months after treatment an improvement of quality of life [ Time Frame: 12 months ]
Percentage of patients obtaining after 3 months of treatment a complete clinical response [ Time Frame: 3 months ]
Percentage of patients obtaining after 6 months of treatment a complete clinical response [ Time Frame: 6 months ]
Percentage of patients obtaining after 12 months of treatment a complete clinical response [ Time Frame: 12 months ]
Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 3 months ]
Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 6 months ]
Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 12 months ]


Enrollment:	10
Study Start Date:	June 2011
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intravenous immunoglobulins Intravenous immunoglobulins	Drug: Intravenous immunoglobulins Single administration of 2 g/kg intravenous immunoglobulins over 2 days Other Name: CLAIRYG

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360658

Locations


France
Regional University Hospital
Besançon, France, 25000
University Hospital
Caen, France, 14033
University Hospital
Grenoble, France, 38043
Regional University Hospital
Lille, France, 59037
University hospital
Limoges, France, 87042
Regional University Hospital
Montpellier, France, 34295
University Hospital
Nancy, France, 54035
University Hospital
Nîmes, France, 30029
Saint louis Hospital
Paris, France, 75475
University Hospital
Reims, France, 51092
University Hospital
Rennes, France, 35033
University Hospital
Toulouse, France, 31059

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Ministry of Health, France

Saint-Louis Hospital, Paris, France

Investigators


Principal Investigator:	François Aubin, Pr	University Hospital of Besançon
Principal Investigator:	Manuelle Viguier, Dr	Saint-Louis Hospital, Paris, France

More Information


Responsible Party:	Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:	NCT01360658 History of Changes
Other Study ID Numbers:	N/2010/57
First Submitted:	May 23, 2011
First Posted:	May 25, 2011
Last Update Posted:	July 30, 2013
Last Verified:	July 2013

Keywords provided by Centre Hospitalier Universitaire de Besancon:


Intravenous immunoglobulins Solar urticaria Minimal urticaria dose Quality of life Safety

Additional relevant MeSH terms:


Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Immunoglobulins	Antibodies Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs

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