ACTIVE_NOT_RECRUITING

Deucravacitinib Adherence Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.

Official Title

Deucravacitinib Adherence Study

Quick Facts

Study Start:2023-07-24

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05570955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Subject must have a working knowledge of English. * Approved birth control methods required for females of childbearing potential. * Baseline TB test.	* Patients without a diagnosis of moderate-to-severe plaque psoriasis. * Patients under 18 years of age. * Patients with severe or unstable comorbid conditions. * Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas). * Patients who are pregnant or breastfeeding. * Patients with any other skin condition that prohibit or confound the ability of the investigator to interpret skin findings. * Patients with active substance or alcohol abuse disorder; or history of substance/alcohol abuse disorder within 6 months prior to study enrollment. * History of, or active, severe depression and/or suicidality. * Patients with active or latent tuberculosis as determined by quant-TB baseline testing * Patients that are taking concomitant biologics, systemics for the treatment of psoriasis and/or phototherapy.

Inclusion Criteria

Exclusion Criteria

* 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.
* Subject must have a working knowledge of English.
* Approved birth control methods required for females of childbearing potential.
* Baseline TB test.

* Patients without a diagnosis of moderate-to-severe plaque psoriasis.
* Patients under 18 years of age.
* Patients with severe or unstable comorbid conditions.
* Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas).
* Patients who are pregnant or breastfeeding.
* Patients with any other skin condition that prohibit or confound the ability of the investigator to interpret skin findings.
* Patients with active substance or alcohol abuse disorder; or history of substance/alcohol abuse disorder within 6 months prior to study enrollment.
* History of, or active, severe depression and/or suicidality.
* Patients with active or latent tuberculosis as determined by quant-TB baseline testing
* Patients that are taking concomitant biologics, systemics for the treatment of psoriasis and/or phototherapy.

Contacts and Locations

Principal Investigator

Steven R Feldman, MD, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Steven R Feldman, MD, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-24

Study Completion Date2026-02

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Psoriasis