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

ConditionBullous Pemphigoid
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patient with bullous pemphigoid

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • IGA score

    Other intervention

    IGA score will be assessed by 2 blinded investigators

  • BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

    Other intervention

    BPDAI will be assessed by 2 by 2 blinded investigators

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patient with bullous pemphigoid2 interventions

Trial outcomes

Primary outcomes

1

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

IGA score : 0 to 4

Time frame
6 months
2

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

BPDAI : 0 to 120

Time frame
6 months

Secondary outcomes

1

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

IGA score : 0 to 4

Time frame
3 months
2

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

IGA score : 0 to 4

Time frame
2 months
3

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

IGA score : 0 to 4

Time frame
1 month
4

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

IGA score : 0 to 4

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: