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Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Saint-Louis Hospital, Paris, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01360658
First received: May 23, 2011
Last updated: July 29, 2013
Last verified: July 2013
  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: 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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 1 month after treatment an improvement of quality of life [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining after 1 month of treatment a complete clinical response [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 3 months after treatment an improvement of quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 6 months after treatment an improvement of quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 12 months after treatment an improvement of quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining after 3 months of treatment a complete clinical response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining after 6 months of treatment a complete clinical response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining after 12 months of treatment a complete clinical response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01360658     History of Changes
Other Study ID Numbers: N/2010/57
Study First Received: May 23, 2011
Last Updated: July 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Intravenous immunoglobulins
Solar urticaria
Minimal urticaria dose
Quality of life
Safety

Additional relevant MeSH terms:
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014