Validation of 5-Point Investigator Global Assessments for Pemphigus

September 16, 2022 updated by: Dedee Murrell, Premier Specialists, Australia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Premier Specialists
        • Sub-Investigator:
          • Anna Wilson
        • Principal Investigator:
          • Dedee Murrell
        • Contact:
          • Bianca Wills
          • Phone Number: 9598 5800
        • Sub-Investigator:
          • Darby Boucher
  • Bulgaria
      • Sofia, Bulgaria
        • Not yet recruiting
        • Medical University of Sofia
        • Contact:
        • Principal Investigator:
          • Snejina Vassileva
        • Sub-Investigator:
          • Kossara Drenovska
  • Greece
      • Thessaloníki, Greece
        • Not yet recruiting
        • Aristotle University of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Aikaterini Patsatsi
  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Not yet recruiting
        • Razi hospital
        • Contact:
        • Principal Investigator:
          • Maryam Daneshpazhooh
  • Israel
      • Tel Aviv, Israel
        • Not yet recruiting
        • Tel Aviv Medical Centre
        • Contact:
        • Principal Investigator:
          • Avital Baniel
  • Singapore
      • Singapore, Singapore
        • Not yet recruiting
        • National University Hospital of Singapore
        • Contact:
        • Principal Investigator:
          • Nisha Chandran
  • Turkey
      • Antalya, Turkey
        • Not yet recruiting
        • Akdeniz University Hospital
        • Contact:
        • Principal Investigator:
          • Asli Bilgic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the special bullous clinic at the lead site's dermatology practice who have been diagnosed with pemphigus.

Description

Inclusion Criteria:

  • Having pemphigus diagnosed by a qualified dermatologist
  • Aged 18 or older at the time of photography

Exclusion Criteria:

  • Those whose photographs are unable to be adequately de-identified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First Scoring Session
Participants whose de-identified photos will be printed in the first booklet for the first 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.
Second Scoring Session
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGA-PV-M (D/P/F), IGA-PV-S (D/P/F), IGA-PF (D/P/F)
Time Frame: Baseline
IGA score of pemphigus severity, possible score from 0-4
Baseline
Pemphigus Disease Activity Index (PDAI) Score
Time Frame: Baseline
Possible score from 0-263
Baseline
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Time Frame: Baseline
Possible score from 0-206
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Premier Specialists, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 21, 2022

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA Pemphigus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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