Study to Assess the Reliability of PASI Scoring Using Digital-Based Images
- Conditions
- Plaque Psoriasis
- Interventions
- Other: In-Person and Remote Disease Assessment
- Registration Number
- NCT05835843
- Lead Sponsor
- Innovaderm Research Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Male and female subjects aged 18 to 75 years, inclusive, at the time of consent.
- 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).
- Subject has plaque psoriasis covering at least 0.5% his/her total BSA at screening/Day 1 visit.
- Subject has a PGA score ≥2 at screening/Day 1 visit.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 3: ≥10% BSA affected In-Person and Remote Disease Assessment Approximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area Cohort 2: ≥5 to <10% BSA affected In-Person and Remote Disease Assessment Approximately 10 subjects with psoriatic plaques covering at least 5% but less than 10% of their body surface area Cohort 1: ≥0.5 to <5% BSA affected In-Person and Remote Disease Assessment Approximately 10 subjects with psoriatic plaques covering at least 0.5% but less than 5% of their body surface area
- Primary Outcome Measures
Name Time Method Intraclass Correlation Coefficient (ICC) between Psoriasis Area and Severity Index (PASI) assessed in-person and using digital photographs, all cohorts combined. Day 1 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Innovaderm Research
🇨🇦Montréal, Quebec, Canada