Validation of 5-Point Investigator Global Assessments for Pemphigus
- Conditions
- Pemphigus
- Interventions
- Other: Investigator Global Assessments (IGAs)
- Registration Number
- NCT05534776
- Lead Sponsor
- Premier Specialists, Australia
- Brief Summary
This study aims to explore the reliability and validity of newly developed Investigator Global Assessments (IGAs) in scoring the severity of pemphigus. IGAs are simple 5-point scales ranging from clear - severe and are preferred by the FDA as endpoints in clinical trials.
- Detailed Description
This study aims to obtain statistical data regarding the inter-rater and intra-rater reliability of the IGAs, Pemphigus Disease Activity Index (PDAI) and Autoimmune Bullous Skin Disease Intensity Score (ABSIS) as well as the convergent validity of the IGAs with the PDAI and objective component of the ABSIS.
Photograph sets of pemphigus lesions will be gathered from the lead site and participant sites. They will be de-identified and printed in a two hardcopy booklets; the first containing 20 photo sets and the second containing 17 new photo sets and 3 repeat photo sets. In the first part of the study, 8 dermatologists will score 20 sets of photographs of pemphigus lesions (a mixture of skin and mucosal lesions), using the IGAs for pemphigus as well as the PDAI and ABSIS. The first booklet will be mailed to dermatologists and they will use the booklet to score each photo set and will submit their scores in a confidential online survey. In the second part of the study, the second booklet will be sent to dermatologists in the same manner 4 weeks later, and each dermatologist will score the photo sets using the same scoring tools. It is estimated that each scoring session will take two hours to complete. Data gathered here will allow for calculation of inter-rater reliability and intra-rater reliability of the IGAs and convergent validity of the IGAs with PDAI and ABSIS.
Later, a sub-study will occur to calculate minimal clinically important differences (MCID) for the IGAs and PDAI. This will involve scoring pemphigus severity of patients at Premier Specialists using PDAI and IGA scores and a Likert score to classify patients as improved, stable or deteriorated compared to previous visits.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Having pemphigus diagnosed by a qualified dermatologist
- Aged 18 or older at the time of photography
- Those whose photographs are unable to be adequately de-identified
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First Scoring Session Investigator Global Assessments (IGAs) Participants whose de-identified photos will be printed in the first booklet for the first scoring session. Second Scoring Session Investigator Global Assessments (IGAs) Participants whose de-identified photos will be printed in the second booklet for the second scoring session.
- Primary Outcome Measures
Name Time Method Pemphigus Disease Activity Index (PDAI) Score Baseline Possible score from 0-263
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) Baseline Possible score from 0-206
IGA-PV-M (D/P/F), IGA-PV-S (D/P/F), IGA-PF (D/P/F) Baseline IGA score of pemphigus severity, possible score from 0-4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Premier Specialists
🇦🇺Kogarah, New South Wales, Australia
Akdeniz University Hospital
🇹🇷Antalya, Turkey
Aristotle University of Thessaloniki
🇬🇷Thessaloníki, Greece
Razi Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Medical University of Sofia
🇧🇬Sofia, Bulgaria
Tel Aviv Medical Centre
🇮🇱Tel Aviv, Israel
National University Hospital of Singapore
🇸🇬Singapore, Singapore