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Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)

Primary Purpose

Solar Urticaria

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Intravenous immunoglobulins
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solar Urticaria focused on measuring Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional University Hospital
  • University Hospital
  • University Hospital
  • Regional University Hospital
  • University hospital
  • Regional University Hospital
  • University Hospital
  • University Hospital
  • Saint louis Hospital
  • University Hospital
  • University Hospital
  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous immunoglobulins

Arm Description

Intravenous immunoglobulins

Outcomes

Primary Outcome Measures

Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2011
Last Updated
July 29, 2013
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Ministry of Health, France, Saint-Louis Hospital, Paris, France
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1. Study Identification

Unique Protocol Identification Number
NCT01360658
Brief Title
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
Acronym
IGUS
Official Title
Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Ministry of Health, France, Saint-Louis Hospital, Paris, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Urticaria
Keywords
Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous immunoglobulins
Arm Type
Experimental
Arm Description
Intravenous immunoglobulins
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulins
Other Intervention Name(s)
CLAIRYG
Intervention Description
Single administration of 2 g/kg intravenous immunoglobulins over 2 days
Primary Outcome Measure Information:
Title
Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time Frame
1 month
Title
Percentage of patients obtaining 1 month after treatment an improvement of quality of life
Time Frame
1 month
Title
Percentage of patients obtaining after 1 month of treatment a complete clinical response
Time Frame
1 month
Title
Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity
Time Frame
1 month
Title
Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time Frame
6 months
Title
Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time Frame
12 months
Title
Percentage of patients obtaining 3 months after treatment an improvement of quality of life
Time Frame
3 months
Title
Percentage of patients obtaining 6 months after treatment an improvement of quality of life
Time Frame
6 months
Title
Percentage of patients obtaining 12 months after treatment an improvement of quality of life
Time Frame
12 months
Title
Percentage of patients obtaining after 3 months of treatment a complete clinical response
Time Frame
3 months
Title
Percentage of patients obtaining after 6 months of treatment a complete clinical response
Time Frame
6 months
Title
Percentage of patients obtaining after 12 months of treatment a complete clinical response
Time Frame
12 months
Title
Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity
Time Frame
3 months
Title
Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity
Time Frame
6 months
Title
Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Aubin, Pr
Organizational Affiliation
University Hospital of Besançon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuelle Viguier, Dr
Organizational Affiliation
Saint-Louis Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional University Hospital
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Regional University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Regional University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
University Hospital
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Saint louis Hospital
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
University Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

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