NCT01360658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

May 23, 2011

Last Update Submit

July 29, 2013

Conditions

Solar Urticaria

Keywords

Intravenous immunoglobulinsSolar urticariaMinimal urticaria doseQuality of lifeSafety

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (15)

  • Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

    1 month

  • Percentage of patients obtaining 1 month after treatment an improvement of quality of life

    1 month

  • Percentage of patients obtaining after 1 month of treatment a complete clinical response

    1 month

  • Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity

    1 month

  • Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

    6 months

  • +10 more secondary outcomes

Study Arms (1)

Intravenous immunoglobulins

EXPERIMENTAL

Intravenous immunoglobulins

Drug: Intravenous immunoglobulins

Interventions

Intravenous immunoglobulinsDRUG

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

Also known as: CLAIRYG
Intravenous immunoglobulins

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Heat triggered urticaria
  • Contra-indications to IVIG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Regional University Hospital

Besançon, 25000, France

Location

University Hospital

Caen, 14033, France

Location

University Hospital

Grenoble, 38043, France

Location

Regional University Hospital

Lille, 59037, France

Location

University hospital

Limoges, 87042, France

Location

Regional University Hospital

Montpellier, 34295, France

Location

University Hospital

Nancy, 54035, France

Location

University Hospital

Nîmes, 30029, France

Location

Saint louis Hospital

Paris, 75475, France

Location

University Hospital

Reims, 51092, France

Location

University Hospital

Rennes, 35033, France

Location

University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Urticaria, Solar

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Photosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesChronic Inducible UrticariaChronic UrticariaUrticariaSkin Diseases, VascularHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • François Aubin, Pr

    University Hospital of Besançon

    PRINCIPAL INVESTIGATOR

  • Manuelle Viguier, Dr

    Saint-Louis Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

FR(12)