Validation of 5-Point Investigator Global Assessments for Pemphigus

NCT05534776 | Unknown

• 1 other identifier: IGA Pemphigus
• Study Type: observational
• Target: 40
• Locations: 7 countries
• Sites: 7

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.

Conditions

Pemphigus

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline

• Pemphigus Disease Activity Index (PDAI) Score

  Possible score from 0-263

  Baseline

• Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)

  Possible score from 0-206

  Baseline

Study Arms (2)

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)

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)

Interventions

Investigator Global Assessments (IGAs) OTHER

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.

First Scoring Session; Second Scoring Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Premier Specialists, Australia: lead

Study Sites (7)

Premier Specialists

Kogarah, New South Wales, 2217, Australia

RECRUITING

Medical University of Sofia

Sofia, Bulgaria

NOT YET RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Greece

NOT YET RECRUITING

Razi Hospital

Tehran, Iran

NOT YET RECRUITING

Tel Aviv Medical Centre

Tel Aviv, Israel

NOT YET RECRUITING

National University Hospital of Singapore

Singapore, Singapore

NOT YET RECRUITING

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Bianca Wills

CONTACT

0452409850; premierspectrialsbianca@gmail.com

Darby Boucher

CONTACT

0426836596; darbyboucher@icloud.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Premier Specialists

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 9, 2022
• Study Start: September 21, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

AU (1); GR (1); IR (1); IL (1); BU (1); SG (1); TU (1)