Bullous PemphigoidIGA scoreNCT05366127
Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
An observational study of Bullous Pemphigoid, run by University Hospital, Rouen at 11 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- IGA score and BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)
- How many people
- 150 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jul 2022to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with bullous pemphigoid
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
Julien BLOT contact
11 sites in 1 country
France11 sites
Bordeaux University Hospital
Bordeaux
Dijon University Hospital
Dijon
Lille University Hospital
Lille
Lyon University Hospital
Lyon
Montpellier University Hospital
Montpellier
Nantes University Hospital
Nantes
Avicennes Hospital
Paris
Frédéric Caux
Bichat Hospital
Paris
Catherine Picard-Dahan
Henri Mondor Hospital
Paris
Saint-Louis Hospital
Paris
Reims University Hospital
Reims
About this study
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
- Conditions
- Bullous Pemphigoid
- Being tested
- IGA score, BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGA scoreOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with bullous pemphigoid | IGA score and BPDAI score will be assessed to patient with bullous pemphigoid Receives: Other: IGA score; Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of IGA Score between baseline and 6-month follow-up visit
IGA score : 0 to 4
Measured: 6 months
BPDAI Score between baseline and 6-month follow-up visit
BPDAI : 0 to 120
Measured: 6 months
Secondary outcomes (12)
Evolution of IGA Score between baseline and 3-month follow-up visit
IGA score : 0 to 4
Measured: 3 months
Evolution of IGA Score between baseline and 2-month follow-up visit
IGA score : 0 to 4
Measured: 2 months
Evolution of IGA Score between baseline and 1-month follow-up visit
IGA score : 0 to 4
Measured: 1 month
Evolution of IGA Score between baseline and 3-weeks follow-up visit
IGA score : 0 to 4
Measured: 3 weeks
Evolution of IGA Score between baseline and 2-weeks follow-up visit
IGA score : 0 to 4
Measured: 2 weeks
Evolution of IGA Score between baseline and 1-week follow-up visit
IGA score : 0 to 4
Measured: 1 week
Evolution of BPDAI Score between baseline and 3-month follow-up visit
BPDAI : 0 to 120
Measured: 3 months
Evolution of BPDAI Score between baseline and 2-month follow-up visit
BPDAI : 0 to 120
Measured: 2 months
Evolution of BPDAI Score between baseline and 1-month follow-up visit
BPDAI : 0 to 120
Measured: 1 month
Evolution of BPDAI Score between baseline and 3 weeks follow-up visit
BPDAI : 0 to 120
Measured: 3 weeks
Evolution of BPDAI Score between baseline and 2 weeks follow-up visit
BPDAI : 0 to 120
Measured: 2 weeks
Evolution of BPDAI Score between baseline and 1 week follow-up visit
BPDAI : 0 to 120
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal JOLY, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366127
- Sponsor's protocol ID
- 2022/0017/OB
- Acronym
- IGA score
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT05366127
- Acronym / sponsor ID
- IGA score / 2022/0017/OB
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with bullous pemphigoid | – | Other: IGA score, Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)IGA score and BPDAI score will be assessed to patient with bullous pemphigoid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with bullous pemphigoid
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGA scoreIGA score will be assessed by 2 blinded investigators | Other | Patient with bullous pemphigoid |
| BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)BPDAI will be assessed by 2 by 2 blinded investigators | Other | Patient with bullous pemphigoid |
Primary outcome
Evolution of IGA Score between baseline and 6-month follow-up visit
Time frame: 6 months
IGA score : 0 to 4
BPDAI Score between baseline and 6-month follow-up visit
Time frame: 6 months
BPDAI : 0 to 120
12 secondary outcomes
Evolution of IGA Score between baseline and 3-month follow-up visit
Time frame: 3 months
Evolution of IGA Score between baseline and 2-month follow-up visit
Time frame: 2 months
Evolution of IGA Score between baseline and 1-month follow-up visit
Time frame: 1 month
Evolution of IGA Score between baseline and 3-weeks follow-up visit
Time frame: 3 weeks
Evolution of IGA Score between baseline and 2-weeks follow-up visit
Time frame: 2 weeks
Evolution of IGA Score between baseline and 1-week follow-up visit
Time frame: 1 week
Evolution of BPDAI Score between baseline and 3-month follow-up visit
Time frame: 3 months
Evolution of BPDAI Score between baseline and 2-month follow-up visit
Time frame: 2 months
Evolution of BPDAI Score between baseline and 1-month follow-up visit
Time frame: 1 month
Evolution of BPDAI Score between baseline and 3 weeks follow-up visit
Time frame: 3 weeks
Evolution of BPDAI Score between baseline and 2 weeks follow-up visit
Time frame: 2 weeks
Evolution of BPDAI Score between baseline and 1 week follow-up visit
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
Related trials for Bullous Pemphigoid
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
Bullous Pemphigoid (BP)
Active, not recruitingPhase 3
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
Severe Forms of Mucous Membrane Pemphigoid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien BLOT contact
Pascal JOLY principal investigator
University Hospital, Rouen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid, run by University Hospital, Rouen at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal JOLY, Pr (+3323288 ext. 8265, pascal.joly@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of IGA Score between baseline and 6-month follow-up visit (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.