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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05835843
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Innovaderm Research Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Robert Bissonnette, MD
Principal Investigator Affiliation Innovaderm Research Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

: Cohort 1: ≥0.5 to <5% BSA affected

Approximately 10 subjects with psoriatic plaques covering at least 0.5% but less than 5% of their body surface area

: Cohort 2: ≥5 to <10% BSA affected

Approximately 10 subjects with psoriatic plaques covering at least 5% but less than 10% of their body surface area

: Cohort 3: ≥10% BSA affected

Approximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Innovaderm Research, Montréal, Quebec, Canada

Status

Recruiting

Address

Innovaderm Research

Montréal, Quebec, H2X 2V1

Site Contact

NAZUK SAYED

sayed@innovaderm.com

5145214285 #337

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