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Trial details imported from ClinicalTrials.gov

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




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

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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05534776