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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Other: In-Person and Remote Disease Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: ≥0.5 to <5% BSA affected<br>Approximately 10 subjects with psoriatic plaques covering at least 0.5% but less than 5% of their body surface area | Other: In-Person and Remote Disease Assessment<br>* 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.<br>|
| Cohort 2: ≥5 to <10% BSA affected<br>Approximately 10 subjects with psoriatic plaques covering at least 5% but less than 10% of their body surface area | Other: In-Person and Remote Disease Assessment<br>* 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.<br>|
| Cohort 3: ≥10% BSA affected<br>Approximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area | Other: In-Person and Remote Disease Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, remote assessment, digital photographs