Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

NCT ID: NCT01360658

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solar Urticaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous immunoglobulins

Intravenous immunoglobulins

Group Type EXPERIMENTAL

Intravenous immunoglobulins

Intervention Type DRUG

Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Interventions

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Intravenous immunoglobulins

Single administration of 2 g/kg intravenous immunoglobulins over 2 days

Intervention Type DRUG

Other Intervention Names

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CLAIRYG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Aubin, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Besançon

Manuelle Viguier, Dr

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

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Regional University Hospital

Besançon, , France

Site Status

University Hospital

Caen, , France

Site Status

University Hospital

Grenoble, , France

Site Status

Regional University Hospital

Lille, , France

Site Status

University hospital

Limoges, , France

Site Status

Regional University Hospital

Montpellier, , France

Site Status

University Hospital

Nancy, , France

Site Status

University Hospital

Nîmes, , France

Site Status

Saint louis Hospital

Paris, , France

Site Status

University Hospital

Reims, , France

Site Status

University Hospital

Rennes, , France

Site Status

University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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N/2010/57

Identifier Type: -

Identifier Source: org_study_id

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