Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

July 29, 2013 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intravenous immunoglobulins
Drug: Intravenous immunoglobulins
Single administration of 2 g/kg intravenous immunoglobulins over 2 days
Other Names:
  • CLAIRYG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Ministry of Health, France
Saint-Louis Hospital, Paris, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (ESTIMATE)

May 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/2010/57

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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