Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria (IGUS)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Besancon
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
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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 (Adult) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01360658
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
| 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 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 |
ClinicalTrials.gov processed this record on September 29, 2016