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NCT Number: NCT01360658

Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

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.

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Key information

Conditions

Solar Urticaria Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Urticaria, Solar

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regional University Hospital, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous immunoglobulins

Drug

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

Other names: CLAIRYG

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 6 months

  6. Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose

    Time frame: 12 months

  7. Percentage of patients obtaining 3 months after treatment an improvement of quality of life

    Time frame: 3 months

  8. Percentage of patients obtaining 6 months after treatment an improvement of quality of life

    Time frame: 6 months

  9. Percentage of patients obtaining 12 months after treatment an improvement of quality of life

    Time frame: 12 months

  10. Percentage of patients obtaining after 3 months of treatment a complete clinical response

    Time frame: 3 months

  11. Percentage of patients obtaining after 6 months of treatment a complete clinical response

    Time frame: 6 months

  12. Percentage of patients obtaining after 12 months of treatment a complete clinical response

    Time frame: 12 months

  13. Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity

    Time frame: 3 months

  14. Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity

    Time frame: 6 months

  15. Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Ministry of Health, France
  • Saint-Louis Hospital, Paris, France

Registry information

Official study title

Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria

Acronym: IGUS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 25, 2011
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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