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Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

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ClinicalTrials.gov Identifier: NCT01360658
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : July 30, 2013
Sponsor:
Collaborators:
Ministry of Health, France
Saint-Louis Hospital, Paris, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solar Urticaria Drug: Intravenous immunoglobulins Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Rhophylac
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intravenous immunoglobulins
Intravenous immunoglobulins
 Drug: Intravenous immunoglobulins
Single administration of 2 g/kg intravenous immunoglobulins over 2 days
Other Name: CLAIRYG


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

Secondary Outcome Measures :
  1. Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 1 month ]
  2. Percentage of patients obtaining 1 month after treatment an improvement of quality of life [ Time Frame: 1 month ]
  3. Percentage of patients obtaining after 1 month of treatment a complete clinical response [ Time Frame: 1 month ]
  4. Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 1 month ]
  5. Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 6 months ]
  6. Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 12 months ]
  7. Percentage of patients obtaining 3 months after treatment an improvement of quality of life [ Time Frame: 3 months ]
  8. Percentage of patients obtaining 6 months after treatment an improvement of quality of life [ Time Frame: 6 months ]
  9. Percentage of patients obtaining 12 months after treatment an improvement of quality of life [ Time Frame: 12 months ]
  10. Percentage of patients obtaining after 3 months of treatment a complete clinical response [ Time Frame: 3 months ]
  11. Percentage of patients obtaining after 6 months of treatment a complete clinical response [ Time Frame: 6 months ]
  12. Percentage of patients obtaining after 12 months of treatment a complete clinical response [ Time Frame: 12 months ]
  13. Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 3 months ]
  14. Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 6 months ]
  15. Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 12 months ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01360658     History of Changes
Other Study ID Numbers: N/2010/57
First Posted: May 25, 2011    Key Record Dates
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