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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05534776




Registration number
NCT05534776
Ethics application status
Date submitted
29/08/2022
Date registered
9/09/2022
Date last updated
19/09/2022

Titles & IDs
Public title
Validation of 5-Point Investigator Global Assessments for Pemphigus
Scientific title
Validation of 5-Point Investigator Global Assessments for Pemphigus
Secondary ID [1] 0 0
IGA Pemphigus
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pemphigus 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Investigator Global Assessments (IGAs)

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

Second Scoring Session - Participants whose de-identified photos will be printed in the second booklet for the second scoring session.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IGA-PV-M (D/P/F), IGA-PV-S (D/P/F), IGA-PF (D/P/F)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Pemphigus Disease Activity Index (PDAI) Score
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Timepoint [3] 0 0
Baseline

Eligibility
Key inclusion criteria
- Having pemphigus diagnosed by a qualified dermatologist

- Aged 18 or older at the time of photography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those whose photographs are unable to be adequately de-identified

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
21/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Greece
State/province [2] 0 0
Thessaloníki
Country [3] 0 0
Iran, Islamic Republic of
State/province [3] 0 0
Tehran
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Aviv
Country [5] 0 0
Singapore
State/province [5] 0 0
Singapore
Country [6] 0 0
Turkey
State/province [6] 0 0
Antalya

Funding & Sponsors
Primary sponsor type
Other
Name
Premier Specialists, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05534776
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bianca Wills
Address 0 0
Country 0 0
Phone 0 0
0452409850
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05534776