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Validation of 5-Point Investigator Global Assessments for Pemphigus

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ClinicalTrials.gov Identifier: NCT05534776
Recruitment Status : Recruiting
First Posted : September 9, 2022
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Dedee Murrell, Premier Specialists, Australia

Study Description
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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.

Condition or disease Intervention/treatment
Pemphigus Other: Investigator Global Assessments (IGAs)

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation of 5-Point Investigator Global Assessments for Pemphigus
Estimated Study Start Date : September 21, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Pemphigus Disease Activity Index (PDAI) Score [ Time Frame: Baseline ]
    Possible score from 0-263

  3. Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [ Time Frame: Baseline ]
    Possible score from 0-206


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534776


Contacts
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Contact: Bianca Wills 0452409850 premierspectrialsbianca@gmail.com
Contact: Darby Boucher 0426836596 darbyboucher@icloud.com

Locations
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Australia, New South Wales
Premier Specialists Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Bianca Wills    9598 5800      
Sub-Investigator: Darby Boucher         
Sub-Investigator: Anna Wilson         
Principal Investigator: Dedee Murrell         
Bulgaria
Medical University of Sofia Not yet recruiting
Sofia, Bulgaria
Contact: Snejina Vassileva       snejinavassileva@gmail.com   
Principal Investigator: Snejina Vassileva         
Sub-Investigator: Kossara Drenovska         
Greece
Aristotle University of Thessaloniki Not yet recruiting
Thessaloníki, Greece
Contact: Aikaterini Patsatsi       katerinapatsatsi@gmail.com   
Principal Investigator: Aikaterini Patsatsi         
Iran, Islamic Republic of
Razi Hospital Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Maryam Daneshpazhooh       maryamdanesh.pj@gmail.com   
Principal Investigator: Maryam Daneshpazhooh         
Israel
Tel Aviv Medical Centre Not yet recruiting
Tel Aviv, Israel
Contact: Avital Baniel       avitalba@tlvmc.gov.il   
Principal Investigator: Avital Baniel         
Singapore
National University Hospital of Singapore Not yet recruiting
Singapore, Singapore
Contact: Nisha Chandran       nishasuch@gmail.com   
Principal Investigator: Nisha Chandran         
Turkey
Akdeniz University Hospital Not yet recruiting
Antalya, Turkey
Contact: Asli Bilgic       aslibilgictemel@gmail.com   
Principal Investigator: Asli Bilgic         
Sponsors and Collaborators
Premier Specialists, Australia
More Information
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Responsible Party: Dedee Murrell, Professor, Director of Premier Specialists, Premier Specialists, Australia
ClinicalTrials.gov Identifier: NCT05534776    
Other Study ID Numbers: IGA Pemphigus
First Posted: September 9, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases