History of Changes for Study: NCT05534776

Validation of 5-Point Investigator Global Assessments for Pemphigus

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			September 7, 2022	None (earliest Version on record)
2			September 16, 2022	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	IGA Pemphigus
Brief Title:	Validation of 5-Point Investigator Global Assessments for Pemphigus
Official Title:	Validation of 5-Point Investigator Global Assessments for Pemphigus
Secondary IDs:

Study Status


Record Verification:	September 2022
Overall Status:	Recruiting
Study Start:	September 1, 2022
Primary Completion:	August 30, 2023 [Anticipated]
Study Completion:	August 30, 2023 [Anticipated]

First Submitted:	August 29, 2022
First Submitted that Met QC Criteria:	September 7, 2022
First Posted:	September 9, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	September 7, 2022
Last Update Posted:	September 9, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Premier Specialists, Australia
Responsible Party:	Principal Investigator Investigator: Dedee Murrell Official Title: Professor, Director of Premier Specialists Affiliation: Premier Specialists, Australia
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

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.

Conditions


Conditions:	Pemphigus
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Other
Time Perspective:	Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment:	40 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
First Scoring Session Participants whose de-identified photos will be printed in the first booklet for the first scoring session.	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.	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


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


Study Population:	Patients of the special bullous clinic at the lead site's dermatology practice who have been diagnosed with pemphigus.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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/Locations


Central Contact Person:	Bianca Wills Telephone: 0452409850 Email: premierspectrialsbianca@gmail.com
Central Contact Backup:	Darby Boucher Telephone: 0426836596 Email: darbyboucher@icloud.com
Locations:	Australia, New South Wales
	Premier Specialists [Recruiting] Kogarah, New South Wales, Australia, 2217 Contact:Contact: Bianca Wills 9598 5800 Contact:Sub-Investigator: Darby Boucher Contact:Sub-Investigator: Anna Wilson Contact:Principal Investigator: Dedee Murrell
	Bulgaria
	Medical University of Sofia [Not yet recruiting] Sofia, Bulgaria Contact:Contact: Snejina Vassileva snejinavassileva@gmail.com Contact:Principal Investigator: Snejina Vassileva Contact:Sub-Investigator: Kossara Drenovska
	Greece
	Aristotle University of Thessaloniki [Not yet recruiting] Thessaloníki, Greece Contact:Contact: Aikaterini Patsatsi katerinapatsatsi@gmail.com Contact:Principal Investigator: Aikaterini Patsatsi
	Iran, Islamic Republic of
	Razi Hospital [Not yet recruiting] Tehran, Iran, Islamic Republic of Contact:Contact: Maryam Daneshpazhooh maryamdanesh.pj@gmail.com Contact:Principal Investigator: Maryam Daneshpazhooh
	Israel
	Tel Aviv Medical Centre [Not yet recruiting] Tel Aviv, Israel Contact:Contact: Avital Baniel avitalba@tlvmc.gov.il Contact:Principal Investigator: Avital Baniel
	Singapore
	National University Hospital of Singapore [Not yet recruiting] Singapore, Singapore Contact:Contact: Nisha Chandran nishasuch@gmail.com Contact:Principal Investigator: Nisha Chandran
	Turkey
	Akdeniz University Hospital [Not yet recruiting] Antalya, Turkey Contact:Contact: Asli Bilgic aslibilgictemel@gmail.com Contact:Principal Investigator: Asli Bilgic

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: