Assessing Psoriasis Treatment Outcomes

NCT07391423 | Not Yet Recruiting

• 1 other identifier: IRB00142799
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

Psoriasis Treatment Outcomes; medication adherence; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm

  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

  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 Outcomes (3)

• Rate of Adherence

  Week 4

• Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1

  Baseline, Week 4

• Rate of adverse events

  Week 4

Study Arms (3)

AI intervention group

EXPERIMENTAL

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

Human intervention group

EXPERIMENTAL

Subjects will receive BD and receive weekly video calls from study staff

Behavioral: Human

Standard of Care Group

OTHER

Subjects will receive BD and scheduled for a single follow up visit in 4 weeks

Other: Standard of Care

Interventions

Artificial intelligence BEHAVIORAL

patients will receive BD and have a weekly virtual visit with an AIGPP

Also known as: Artificial intelligence (AI)

AI intervention group

Human BEHAVIORAL

patients will receive BD and receive weekly video calls from study staff

Human intervention group

Standard of Care OTHER

patients will receive BD and scheduled for a single follow up visit in 4 weeks

Standard of Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psoriasis; Medication Adherence

Interventions

Artificial Intelligence; Standard of Care

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Steven R Feldman, M.D., Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma M Richardson, MHA

CONTACT

336-716-2903; irma.richardson@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)