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NCT Number: NCT05366127

Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid

The aim of the study is to validate a global and simple score : IGA (Investigator Global Assessment) score for the evaluation of the extent and severity of the disease in patients with bullous pemphigoid

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Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital, Bordeaux, France

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Who can participate

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

Inclusion criteria

  • Consecutive adult patients aged ≥ 18 years
  • Newly diagnosed or relapsing BP
  • Clinical features suggestive of classic BP AND suggestive histological features AND deposition of IgG and/ or C3 deposits on the dermal epiderma junction, AND detection of circulating anti-epidermal antibodies labelling the epidermal side of salt-split skin
  • Patient having read and understood the information letter and not opposed to participation
  • Must be willing and able to adhere to all specified requirements, including but not limited to adherence to the follow-up visits

Exclusion criteria

  • Predominant or exclusive mucosal involvement leading to suspect the diagnosis of mucous membrane pemphigoid
  • Pemphigoid gestationis
  • Linear IgA dermatosis (predominant or exclusive IgA deposits on the DEJ)
  • Skin lesions suggesting the diagnosis of epidermolysis bullosa acquisita (skin fragility, atrophy, milia)

Treatment and study plan

IGA score

Other

IGA score will be assessed by 2 blinded investigators

BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

Other

BPDAI will be assessed by 2 by 2 blinded investigators

Primary outcomes

  1. Evolution of IGA Score between baseline and 6-month follow-up visit

    Time frame: 6 months

    IGA score : 0 to 4

  2. BPDAI Score between baseline and 6-month follow-up visit

    Time frame: 6 months

    BPDAI : 0 to 120

Secondary outcomes

  1. Evolution of IGA Score between baseline and 3-month follow-up visit

    Time frame: 3 months

    IGA score : 0 to 4

  2. Evolution of IGA Score between baseline and 2-month follow-up visit

    Time frame: 2 months

    IGA score : 0 to 4

  3. Evolution of IGA Score between baseline and 1-month follow-up visit

    Time frame: 1 month

    IGA score : 0 to 4

  4. Evolution of IGA Score between baseline and 3-weeks follow-up visit

    Time frame: 3 weeks

    IGA score : 0 to 4

  5. Evolution of IGA Score between baseline and 2-weeks follow-up visit

    Time frame: 2 weeks

    IGA score : 0 to 4

  6. Evolution of IGA Score between baseline and 1-week follow-up visit

    Time frame: 1 week

    IGA score : 0 to 4

  7. Evolution of BPDAI Score between baseline and 3-month follow-up visit

    Time frame: 3 months

    BPDAI : 0 to 120

  8. Evolution of BPDAI Score between baseline and 2-month follow-up visit

    Time frame: 2 months

    BPDAI : 0 to 120

  9. Evolution of BPDAI Score between baseline and 1-month follow-up visit

    Time frame: 1 month

    BPDAI : 0 to 120

  10. Evolution of BPDAI Score between baseline and 3 weeks follow-up visit

    Time frame: 3 weeks

    BPDAI : 0 to 120

  11. Evolution of BPDAI Score between baseline and 2 weeks follow-up visit

    Time frame: 2 weeks

    BPDAI : 0 to 120

  12. Evolution of BPDAI Score between baseline and 1 week follow-up visit

    Time frame: 1 week

    BPDAI : 0 to 120

Study contacts

Contact information is provided by the study sponsor or research team.

Julien BLOT

CONTACT

[email protected]

Pascal JOLY, Pr

CONTACT

[email protected]

+3323288 ext. 8265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: IGA score

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 9, 2022
Registry last updated
May 9, 2022

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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