An observational study in Pemphigus, sponsored by Premier Specialists, Australia. Status unknown at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-19.
Sponsored by Premier Specialists, Australia · Observational
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.
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 21 observational studies indexed under Pemphigus.
Browse Pemphigus studies →Premier Specialists, Australia is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients of the special bullous clinic at the lead site's dermatology practice who have been diagnosed with pemphigus.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants whose de-identified photos will be printed in the first booklet for the first scoring session.
Other: Investigator Global Assessments (IGAs)
Participants whose de-identified photos will be printed in the second booklet for the second scoring session.
Other: Investigator Global Assessments (IGAs)
5-Point scale from 0-4 to score the severity of pemphigus, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe.
IGA-PV-M (D/P/F), IGA-PV-S (D/P/F), IGA-PF (D/P/F)
IGA score of pemphigus severity, possible score from 0-4
Time frame: Baseline
Pemphigus Disease Activity Index (PDAI) Score
Possible score from 0-263
Time frame: Baseline
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Possible score from 0-206
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Aug 2023, 11 months later.
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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Premier Specialists, Australia