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

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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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