ClinicalTrials.gg
Not yet recruitingNCT07391423Updated Nov 5, 2026

Assessing Psoriasis Treatment Outcomes

An interventional study of Artificial intelligence and Human in Psoriasis, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Updated Nov 5, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psoriasis

Keywords

  • Psoriasis Treatment Outcomes
  • medication adherence
  • Artificial intelligence
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 15 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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

  • Experimental
    Human intervention group

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

    Behavioral: Human

  • Other
    Standard of Care Group

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

    Other: Standard of Care

Interventions

  • BehavioralArtificial intelligence

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

    Also known as: Artificial intelligence (AI)

  • BehavioralHuman

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

  • OtherStandard of Care

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 4

  2. 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.

    Time frame: Week 4

Secondary outcomes

  1. Rate of Adherence

    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.

    Time frame: Week 4

  2. Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1

    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)

    Time frame: Baseline, Week 4

  3. Rate of adverse events

    Another secondary outcome will be adverse events, which will be assessed at the study conclusion and will be patient reported.

    Time frame: Week 4

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Oct 2026→Jan 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Oct 2026→Jan 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07391423
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Irma M Richardson, MHA
Contact
irma.richardson@advocatehealth.org
336-716-2903
Steven R Feldman, M.D., Ph.D.
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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