PsoriasisNCT07391423
Assessing Psoriasis Treatment Outcomes
A study testing Artificial intelligence and Human in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Artificial intelligence and Human
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
Irma M Richardson, MHA, 336-716-2903, irma.richardson@advocatehealth.org
336-716-7465
About this study
Official title: 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.
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.
- Conditions
- Psoriasis
- Being tested
- Artificial intelligence, Human, Standard of Care
- Keywords
- Psoriasis Treatment Outcomes, medication adherence, Artificial intelligence
- Medical subject headings
- Psoriasis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligenceBehavioural
Also called Artificial intelligence (AI)
patients will receive BD and have a weekly virtual visit with an AIGPP
HumanBehavioural
patients will receive BD and receive weekly video calls from study staff
Standard of CareOther
patients will receive BD and scheduled for a single follow up visit in 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Artificial intelligence |
| Human intervention group | Experimental | Subjects will receive BD and receive weekly video calls from study staff Receives: Behavioral: Human |
| Standard of Care Group | Other | Subjects will receive BD and scheduled for a single follow up visit in 4 weeks Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Week 4
Secondary outcomes (3)
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.
Measured: Week 4
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)
Measured: Baseline, Week 4
Rate of adverse events
Another secondary outcome will be adverse events, which will be assessed at the study conclusion and will be patient reported.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, M.D., Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391423
- Sponsor's protocol ID
- IRB00142799
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Psoriasis Treatment Outcomes: a Single-center, Prospective Study Evaluating Patient Outcomes in Psoriasis
- ClinicalTrials.gov ID
- NCT07391423
- Acronym / sponsor ID
- IRB00142799
- Conditions
- Psoriasis
- Keywords
- Psoriasis Treatment Outcomes, medication adherence, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI intervention group | Experimental | Behavioral: Artificial intelligenceSubject will receive with topical betamethasone dipropionate cream (BD) and have a weekly virtual visit with an AI-generated automated physician provider (AIGPP). |
| Human intervention group | Experimental | Behavioral: HumanSubjects will receive BD and receive weekly video calls from study staff |
| Standard of Care Group | Other | Other: Standard of CareSubjects will receive BD and scheduled for a single follow up visit in 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligenceAlso: Artificial intelligence (AI)patients will receive BD and have a weekly virtual visit with an AIGPP | Behavioural | AI intervention group |
| Humanpatients will receive BD and receive weekly video calls from study staff | Behavioural | Human intervention group |
| Standard of Carepatients will receive BD and scheduled for a single follow up visit in 4 weeks | Other | Standard of Care Group |
Primary outcome
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.
3 secondary outcomes
Rate of Adherence
Time frame: Week 4
Rate of PASI75, PASI90, PASI100, and IGA of 0 or 1
Time frame: Baseline, Week 4
Rate of adverse events
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven R Feldman, M.D., Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence and Human in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma M Richardson, MHA (336-716-2903, irma.richardson@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to implement AIGPP system and Rate of dropout in AIGPP trial arm (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.