Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157, United States
Location contact
Irma M Richardson, MHA
CONTACT
Steven R Feldman, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
CONTACT
Not Yet Recruiting
NCT Number: NCT07391423
Assessing Psoriasis Treatment Outcomes
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Artificial intelligence
Behavioralpatients will receive BD and have a weekly virtual visit with an AIGPP
Other names: Artificial intelligence (AI)
Human
Behavioralpatients will receive BD and receive weekly video calls from study staff
Standard of care
Otherpatients will receive BD and scheduled for a single follow up visit in 4 weeks
Primary outcomes
-
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
-
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.
Secondary outcomes
-
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.
-
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)
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Wake Forest University Health Sciences
Other
Registry information
Official study title
Assessing Psoriasis Treatment Outcomes: a Single-center, Prospective Study Evaluating Patient Outcomes in Psoriasis
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Feb 5, 2026
- Registry last updated
- Apr 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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