- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05621369
Psorcast Mobile Study
May 28, 2026 updated by: Sage Bionetworks
Psorcast Study: A Smartphone-based Study of Psoriasis and Psoriatic Arthritis
The purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements.
This study uses an iPhone app to record these symptoms through questionnaires and sensors.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Psoriatic disease exhibits a spectrum of symptoms and can transition from psoriasis (PsO), largely affecting the skin, to psoriatic arthritis (PsA) involving widespread musculoskeletal inflammation.
Early detection of the PsO-to-PsA transition and rapid administration of effective treatment is essential, as a delay in diagnosing PsA by as little as 6 months can lead to irreversible joint damage.
This "ticking clock" paradigm drives the need for frequent monitoring and effective therapeutic intervention as early as possible to attenuate or possibly prevent disease progression.
Using a suite of smartphone-based measurements in an app called Psorcast (psoriasis forecasts), we aim to aggregate weekly, symptom measurements from participants in a remote, longitudinal observational study to map the trajectories of treatment response and disease progression.
In this study, we will explore measurements of psoriatic disease activity at least an order of magnitude more frequently (weekly vs. quarterly) than standard clinical practice or clinical trial designs.
This study is not meant to provide a medical diagnosis, treatment, or medical advice.
It is meant to provide a scalable, inexpensive, non-invasive and frequent measure and tracking of psoriasis and psoriatic arthritis for research purposes.
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Sage Bionetworks
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adults with a compatible iPhone or iPod Touch who consent to particpate
Description
Inclusion Criteria:
- Adult age 18 and older who consent to participate in the study
- Own a compatible iPhone or iPod Touch device running iOS 12.2 or above
- Be able to read and understand an official language of the country of participation
Exclusion Criteria:
- Age 17 years or younger
- Not a resident of the a country where the app is approved for use
- Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
- Not be able to read and understand an official language of the country of participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants with Psoriasis
People who report a diagnosis of Psoriasis.
Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).
|
At enrollment, participants are asked to complete a baseline health history, family history, and a participant-reported symptom inventory.
Participants are asked to draw the location and size of psoriasis they currently experience.
Participants are provided a body template onto which they can draw on their screen.
Investigators estimate the percentage of body area affected.
Participants are asked to take a picture of a representative psoriasis plaque and indicate the location of the plaque.
They are asked to take a picture of the same area over time.
The investigators are developing computer vision algorithms to assess the plaque.
Participants are asked to take pictures of the back of each hand and the top of each foot.
These photos can be used to assess finger and toe swelling as well as psoriatic nail involvement.
The investigators are developing computer vision algorithms to assess psoriatic nail involvement and digit swelling.
Participants are asked to internally and externally rotate the phone as it rests on a flat surface.
Participants perform each direction (internal and external) and each arm (left and right) in turn.
Gyroscope sensors measure the degree of rotation.
Participants are asked to walk in a straight line for 30 seconds.
Gait is measured by gyroscope and accelerometer sensors.
The investigators examine step-dependent and sequence-dependent features from these sensors.
The investigators apply feature selection and classifier algorithms to analyze these data.
Participants complete all described behavioral interventions via a dedicated iPhone app, Psorcast.
|
|
Participants with Psoriatic Arthritis
People who report a diagnosis of Psoriatic Arthritis.
Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).
|
At enrollment, participants are asked to complete a baseline health history, family history, and a participant-reported symptom inventory.
Participants are asked to draw the location and size of psoriasis they currently experience.
Participants are provided a body template onto which they can draw on their screen.
Investigators estimate the percentage of body area affected.
Participants are asked to take a picture of a representative psoriasis plaque and indicate the location of the plaque.
They are asked to take a picture of the same area over time.
The investigators are developing computer vision algorithms to assess the plaque.
Participants are asked to take pictures of the back of each hand and the top of each foot.
These photos can be used to assess finger and toe swelling as well as psoriatic nail involvement.
The investigators are developing computer vision algorithms to assess psoriatic nail involvement and digit swelling.
Participants are asked to internally and externally rotate the phone as it rests on a flat surface.
Participants perform each direction (internal and external) and each arm (left and right) in turn.
Gyroscope sensors measure the degree of rotation.
Participants are asked to walk in a straight line for 30 seconds.
Gait is measured by gyroscope and accelerometer sensors.
The investigators examine step-dependent and sequence-dependent features from these sensors.
The investigators apply feature selection and classifier algorithms to analyze these data.
Participants complete all described behavioral interventions via a dedicated iPhone app, Psorcast.
|
|
Participants without Psoriasis or Psoriatic Arthritis
People who report no prior diagnosis of Psoriasis or Psoriatic Arthritis.
Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).
|
At enrollment, participants are asked to complete a baseline health history, family history, and a participant-reported symptom inventory.
Participants are asked to draw the location and size of psoriasis they currently experience.
Participants are provided a body template onto which they can draw on their screen.
Investigators estimate the percentage of body area affected.
Participants are asked to take a picture of a representative psoriasis plaque and indicate the location of the plaque.
They are asked to take a picture of the same area over time.
The investigators are developing computer vision algorithms to assess the plaque.
Participants are asked to take pictures of the back of each hand and the top of each foot.
These photos can be used to assess finger and toe swelling as well as psoriatic nail involvement.
The investigators are developing computer vision algorithms to assess psoriatic nail involvement and digit swelling.
Participants are asked to internally and externally rotate the phone as it rests on a flat surface.
Participants perform each direction (internal and external) and each arm (left and right) in turn.
Gyroscope sensors measure the degree of rotation.
Participants are asked to walk in a straight line for 30 seconds.
Gait is measured by gyroscope and accelerometer sensors.
The investigators examine step-dependent and sequence-dependent features from these sensors.
The investigators apply feature selection and classifier algorithms to analyze these data.
Participants complete all described behavioral interventions via a dedicated iPhone app, Psorcast.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Results of participant self-assessment surveys
Time Frame: Through study completion, an average of 2 years
|
Results of participant self-assessment surveys will be analyzed using descriptive statistics.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Body surface area and location from the Psoriasis Draw assessment
Time Frame: Through study completion, an average of 2 years
|
The investigators will quantify body surface area and psoriasis area hotspots across the cohort.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Computer vision features from Psoriasis Area Photo assessment
Time Frame: Through study completion, an average of 2 years
|
The investigators apply visual processing and classifier algorithms to analyze the images from the Psoriasis Area Photo assessments.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Computer vision features from Finger/Toe Photos
Time Frame: Through study completion, an average of 2 years
|
The investigators apply visual processing and classifier algorithms to segment nails and joints from hand and foot photos.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Gyroscope and accelerometer sensor measurements from Digital Jar Open assessment
Time Frame: Through study completion, an average of 2 years
|
The investigators examine rotational features from gyroscope and accelerometer sensors.
The investigators apply feature selection and classifier algorithms to analyze these data.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Gyroscope and accelerometer sensor measurements from 30-sec Walk assessment
Time Frame: Through study completion, an average of 2 years
|
The investigators examine step-dependent and sequence-dependent features from gyroscope and accelerometer sensors.
The investigators apply feature selection and classifier algorithms to analyze these data.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
|
Quantification and distribution of self-reported painful joints
Time Frame: Through study completion, an average of 2 years
|
The investigators will quantify the self-reported painful joints and, in particular, compare to measurements from the 30-sec Walk and Digital Jar Open to identify correlations.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
App usage data for assessment of participant engagement
Time Frame: Through study completion, an average of 2 years
|
App usage data is used to gauge participant engagement throughout the study period.
These results may also be compared with other intervention results.
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Solveig Sieberts, Ph.D, Sage Bionetworks
- Principal Investigator: Jose Scher, MD, NYU Langone Medical Center
- Principal Investigator: Joseph Merola, MD, MMSc, Brigham and Women's Hospital & Harvard Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- DE Webster, RH Haberman, LM Perez Chada, M Tummalacherla, A Tediarjo, V Yadav, E Chaibub Neto, W MacDuffie, M DePhillips, E Sieg, S Catron, C Grant, W Francis, M Nguyen, M Yussuff, RL Castillo, D Yan, AL Neimann, SM Reddy, A Ogdie, A Kolivras, MR Kellen, LM Mangravite, SK Sieberts, L Omberg, JF Merola, JU Scher medRxiv 2022.04.13.22273676; doi: https://doi.org/10.1101/2022.04.13.22273676
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
November 10, 2022
First Submitted That Met QC Criteria
November 10, 2022
First Posted (Actual)
November 18, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Connective Tissue Diseases
- Spinal Diseases
- Spondylarthropathies
- Skin Diseases, Papulosquamous
- Spondylarthritis
- Spondylitis
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Arthralgia
- Psoriasis
- Arthritis, Psoriatic
- Skin Diseases
- Collagen Diseases
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
- Locomotion
- Walking
Other Study ID Numbers
- 202110921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will share the de-identified data from participants who opt-in to data sharing during enrollment and consent.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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