Plaque Psoriasis
Conditions
Keywords
psoriasis, remote assessment, digital photographs
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.
Interventions
OTHERIn-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.
Sponsors
Innovaderm Research Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraclass Correlation Coefficient (ICC) between Physician's Global Assessment (PGA) assessed in-person and using digital photographs, all cohorts combined and by cohort. | Day 1 | The PGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity. |
| Intraclass Correlation Coefficient (ICC) between Body Surface Area (BSA) assessed in-person and using digital photographs, all cohorts combined and by cohort. | Day 1 | The %BSA affected by psoriasis will be evaluated from 1 to 100%. |
| Intraclass Correlation Coefficient (ICC) between PASI assessed in-person and using digital photographs, by cohort. | Day 1 | — |
| Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by the same assessor. | Day 1 | This outcome measure will assess the variation in PASI scores when evaluated multiple times by the same assessor using digital photographs (intra-rater variability). |
| Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by 2 assessors. | Day 1 | This outcome measure will assess agreement between assessors using digital photographs (inter-rater variability). |
Countries
Canada
Outcome results
None listed