Assessing Psoriasis Treatment Outcomes

April 27, 2026 updated by: Wake Forest University Health Sciences

Assessing Psoriasis Treatment Outcomes: a Single-center, Prospective Study Evaluating Patient Outcomes in Psoriasis

To assess the feasibility of AIGPP video interactions with psoriasis patients. To explore patient attitudes, trust, and comfort levels concerning AIGPP interactions in a healthcare setting, and to understand their influence on the patient-physician dynamic. To evaluate medication adherence over a 4-week period in patients with psoriasis randomized to weekly AI-generated automated physician providers (AIGPP) video interactions, weekly human video calls, or standard care (single follow up visit after 4 weeks). Adherence rates will be evaluated via a cap designed to record adherence attached to the study medication container.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Psoriasis is a chronic disease that can negatively impact quality of life. However, adherence to topical treatment for psoriasis can be abysmal. Nonadherence can result in multiple negative effects, including treatment failure, increased healthcare costs, and decreased quality of life. Office visits can drive compliance behavior. By using "white coat compliance," providers increase adherence in the short period before and after a doctor appointment. However, frequent visits may not be feasible for time-constrained healthcare providers. Artificial intelligence (AI) has alleviated provider burden in other settings and may be applied in promoting medication adherence through AI-generated automated physician provider (AIGPP) visits. Given limited funding, this pilot study will assess the feasibility of AIGPP interactions with psoriasis patients treated with betamethasone dipropionate cream (BD).

To accomplish this, up to 15 subjects, age 18 years of age and older, with psoriasis will be recruited to participate. Subjects who meet inclusion criteria will complete a demographic questionnaire and will be randomized to one of three arms (1. AI intervention group - patients will receive BD and have a weekly virtual visit with an AIGPP, 2. human intervention group - patients will receive BD and receive weekly video calls from study staff, 3. standard of care group - patients will receive BD and scheduled for a single follow up visit in 4 weeks). The subjects will receive the BD with a Sensal MyAide adherence device attached.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences Department of Dermatology
        • Contact:
        • Contact:
          • Phone Number: 336-716-7465
        • Principal Investigator:
          • Steven R Feldman, M.D., Ph.D.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥18 years of age
  • Patients with a current diagnosis of psoriasis suitable for treatment with topical Betamethasone (BD)
  • Patients who live in the United States
  • Patients with a sufficient command of the English language
  • Patients with a mobile device able to at least operate at 25 frames per second (FPS).

Exclusion Criteria:

  • Patients less than the age of 18
  • Patients with severe or unstable comorbid conditions
  • Patient who are pregnant or breastfeeding
  • Patients with any other skin conditions that prohibit or confound the ability of the investigator to interpret skin findings
  • Patients that are taking concomitant topical or systemic therapy for the treatment of psoriasis and/or phototherapy
  • Patients without mobile devices able to at least operate at 25 frames per second (FPS).
  • Patients without a current diagnosis of psoriasis suitable for treatment with topical BD

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI intervention group
Subject will receive with topical betamethasone dipropionate cream (BD) and have a weekly virtual visit with an AI-generated automated physician provider (AIGPP).
Behavioral: Artificial intelligence
patients will receive BD and have a weekly virtual visit with an AIGPP
Other Names:
  • Artificial intelligence (AI)
Experimental: Human intervention group
Subjects will receive BD and receive weekly video calls from study staff
Behavioral: Human
patients will receive BD and receive weekly video calls from study staff
Other: Standard of Care Group
Subjects will receive BD and scheduled for a single follow up visit in 4 weeks
Other: Standard of Care
patients will receive BD and scheduled for a single follow up visit in 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm
Time Frame: Week 4
One primary outcome of the study is the feasibility of AIGPP interactions with psoriasis patients, which will be measured as whether we can create & implement the AIGPP system and the dropout rate in the AIGPP arm
Week 4
Thematic analysis of qualitative interviews regarding psoriasis patients' attitudes, trust, and comfort levels with AIGPP interactions in a healthcare setting
Time Frame: Week 4
Another primary outcome will be psoriasis patients' attitudes, trust, and comfort levels with AIGPP interactions in a healthcare setting, which will be measured by semi-structured qualitative interviews analyzed via a thematic analysis.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Adherence
Time Frame: Week 4
One secondary outcome is adherence, which will be measured as a continuous variable as the number of days the study medication is used divided by the number of study days.
Week 4
Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1
Time Frame: Baseline, Week 4
Another secondary outcome is efficacy, which will be measured as 75% improvement in Psoriasis Area and Severity Index (PASI75), 90% improvement in PASI (PASI90), and 100% improvement in PASI (PASI100). Efficacy will also be measured as the rate of Investigator Global Assessment (IGA) of 0 (clear) and 1 (almost clear)
Baseline, Week 4
Rate of adverse events
Time Frame: Week 4
Another secondary outcome will be adverse events, which will be assessed at the study conclusion and will be patient reported.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Steven R Feldman, M.D., Ph.D., Wake Forest University Health Sciences

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00142799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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