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Text Reminders for Psoriasis Treatment Adherence

N/A

Recruiting

Led By Steven R Feldman, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with moderate-to-severe plaque psoriasis. Standard criteria for moderate-to-severe plaque psoriasis will be used (BSA greater than or equal to 3% or face/palm/sole/genital involvement or severe effect on Quality of Life).

Subject must be 18 years of age or older.

Must not have

Patients without a diagnosis of moderate-to-severe plaque psoriasis.

Patients under 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month close-out visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore why psoriasis patients are not following topical treatments and ways to improve adherence to improve treatment outcomes.

Who is the study for?

This trial is for adults with moderate-to-severe plaque psoriasis who speak English and can use approved birth control if necessary. They must have a TB test done at baseline. People with other skin conditions, pregnant or breastfeeding women, those without this type of psoriasis, under 18s, patients with severe health issues or cancer in the last 5 years, on certain other psoriasis treatments, or with recent substance abuse problems cannot join.

What is being tested?

The study tests whether text reminders can help people stick to their treatment plan for deucravacitinib better than no reminders. Forty patients will be split into two groups: one receiving reminders and the other not. The study aims to understand what makes someone more likely to follow their treatment and compare how well the drug works between these two groups.

What are the potential side effects?

While specific side effects are not listed here as it's an adherence study rather than a drug trial per se, generally speaking deucravacitinib may cause infections due to immune system effects; however, participants should discuss potential side effects of deucravacitinib with their healthcare provider.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate-to-severe plaque psoriasis affecting my quality of life or certain body areas.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have moderate-to-severe plaque psoriasis.

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I am under 18 years old.

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I am currently using treatments like biologics or phototherapy for psoriasis.

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I have a history of severe depression or thoughts of suicide.

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I have been tested for tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month close-out visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month close-out visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month close-out visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identify Adherence to treatment

Secondary study objectives

Disease Clarity - Investigator's Global Assessment (IGA) Scale

Psoriasis Treatment Efficacy (PASI 100)

Psoriasis Treatment Efficacy (PASI 75)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

50% of subjects will be randomized to a reporting tool designed to promote better adherence to treatment by having subjects report their progress on a weekly basis (the goal is not to test this tool but to help assure there is a broad range of adherence behavior including some positive adherence outliers)

Group II: No InterventionActive Control1 Intervention

50% of subjects will not receive additional outreach to improve adherence

0 / 7Eligibility criteria met