Study to Assess the Reliability of PASI Scoring Using Digital-Based Images

Plaque Psoriasis Clinical Trial

Official title:

Study to Assess the Reliability of Psoriasis Area Severity Index Scoring Using Digital-Based Images Compared to In-Person Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835843
• Other study ID #: INNO-5033
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: Innovaderm Research Inc.
• Contact: Dominique Dufour Bergeron, MSc
• Phone: 1-866-575-3111
• Email: ddbergeron[@]innovaderm.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an open-labeled study to evaluate the reliability of digital photographs for the remote assessment of the disease severity of plaque psoriasis.

Description:

This study is being conducted to evaluate the reliability of digital photography for the remote assessment of psoriasis disease severity using the Psoriasis Area and Severity Index (PASI) compared to in-person evaluations. Approximately 30 adult subjects will undergo in-person assessments of the severity of the disease and have digital photographs taken for comparative remote evaluations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects aged 18 to 75 years, inclusive, at the time of consent.

2. Subject has at least a 6-month history of plaque psoriasis prior to screening visit (information obtained from medical chart or subject's physician, or directly from the subject).

3. Subject has plaque psoriasis covering at least 0.5% his/her total BSA at screening/Day 1 visit.

4. Subject has a PGA score =2 at screening/Day 1 visit.

Exclusion Criteria:

1. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Other:
• In-Person and Remote Disease Assessment
Disease severity will be assessed during the in-person visit and standardized digital photographs of different body regions and/or the full body will be collected for remote evaluations by external dermatologists.

Locations

Country	Name	City	State
Canada	Innovaderm Research	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Innovaderm Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraclass Correlation Coefficient (ICC) between Physician's Global Assessment (PGA) assessed in-person and using digital photographs, all cohorts combined and by cohort.	The PGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity.	Day 1
Other	Intraclass Correlation Coefficient (ICC) between Body Surface Area (BSA) assessed in-person and using digital photographs, all cohorts combined and by cohort.	The %BSA affected by psoriasis will be evaluated from 1 to 100%.	Day 1
Other	Intraclass Correlation Coefficient (ICC) between PASI assessed in-person and using digital photographs, by cohort.		Day 1
Other	Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by the same assessor.	This outcome measure will assess the variation in PASI scores when evaluated multiple times by the same assessor using digital photographs (intra-rater variability).	Day 1
Other	Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by 2 assessors.	This outcome measure will assess agreement between assessors using digital photographs (inter-rater variability).	Day 1
Primary	Intraclass Correlation Coefficient (ICC) between Psoriasis Area and Severity Index (PASI) assessed in-person and using digital photographs, all cohorts combined.	The PASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions, with adjustments for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.	Day 1