Clinical trial NCT05835843: Study to Assess the Reliability of PASI Scoring Using Digital-Based Images
Official title: Study to Assess the Reliability of Psoriasis Area Severity Index Scoring Using Digital-Based Images Compared to In-Person Evaluation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Plaque Psoriasis
Keywords: psoriasis
remote assessment
digital photographs
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects with at least 0.5% their total BSA affected by plaque psoriasis.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraclass Correlation Coefficient (ICC) between Psoriasis Area and Severity Index (PASI) assessed in-person and using digital photographs, all cohorts combined.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Intraclass Correlation Coefficient (ICC) between Physician's Global Assessment (PGA) assessed in-person and using digital photographs, all cohorts combined and by cohort.
timeFrame: Day 1
measure: Intraclass Correlation Coefficient (ICC) between Body Surface Area (BSA) assessed in-person and using digital photographs, all cohorts combined and by cohort.
timeFrame: Day 1
measure: Intraclass Correlation Coefficient (ICC) between PASI assessed in-person and using digital photographs, by cohort.
timeFrame: Day 1
measure: Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by the same assessor.
timeFrame: Day 1
measure: Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by 2 assessors.
timeFrame: Day 1
Locations:
city: Montréal
country: Canada
facility: Innovaderm Research
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: