Clinical trial NCT05366127: Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
Official title: Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bullous Pemphigoid
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with bullous pemphigoid

Brief summary: 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: 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)

Primary outcomes:
measure: Evolution of IGA Score between baseline and 6-month follow-up visit
timeFrame: 6 months
measure: BPDAI Score between baseline and 6-month follow-up visit
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of IGA Score between baseline and 3-month follow-up visit
timeFrame: 3 months
measure: Evolution of IGA Score between baseline and 2-month follow-up visit
timeFrame: 2 months
measure: Evolution of IGA Score between baseline and 1-month follow-up visit
timeFrame: 1 month
measure: Evolution of IGA Score between baseline and 3-weeks follow-up visit
timeFrame: 3 weeks
measure: Evolution of IGA Score between baseline and 2-weeks follow-up visit
timeFrame: 2 weeks
measure: Evolution of IGA Score between baseline and 1-week follow-up visit
timeFrame: 1 week
measure: Evolution of BPDAI Score between baseline and 3-month follow-up visit
timeFrame: 3 months
measure: Evolution of BPDAI Score between baseline and 2-month follow-up visit
timeFrame: 2 months
measure: Evolution of BPDAI Score between baseline and 1-month follow-up visit
timeFrame: 1 month
measure: Evolution of BPDAI Score between baseline and 3 weeks follow-up visit
timeFrame: 3 weeks
measure: Evolution of BPDAI Score between baseline and 2 weeks follow-up visit
timeFrame: 2 weeks
measure: Evolution of BPDAI Score between baseline and 1 week follow-up visit
timeFrame: 1 week
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Avicennes Hospital
city: Paris
country: France
facility: Bichat Hospital
city: Paris
country: France
facility: Henri Mondor Hospital
city: Paris
country: France
facility: Saint-Louis Hospital
city: Reims
country: France
facility: Reims University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Pascal JOLY
role: PRINCIPAL_INVESTIGATOR
References: