Study Stopped
Terminated IRB approval 6/26/2024, study was never initiated or activated
Adherence to Otezla
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2025
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMay 29, 2025
May 1, 2025
5 months
October 13, 2022
May 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Medication Adherence Outlier
Identify adherence outliers (high and low adherence). Adherence will be determined by the data retrieved from the electronic monitor that is placed on the medication bottle to provide the days and times the bottle is opened to take the medication.
Month 6
Secondary Outcomes (2)
Difference of Efficacy among high adherent subjects
Month 6
Difference of Safety among low adherent subjects
Month 6
Study Arms (3)
Arm 1 - Standard of Care
ACTIVE COMPARATORParticipant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit
Arm 2 - Reminder text
EXPERIMENTALParticipant will be given the medication with an electronic monitoring cap attached and receive weekly electronic text/email-based reporting intervention that is designed to promote better adherence to treatment (to help assure that the study have subjects who have excellent adherence. Having patients report their progress on a regular basis promotes better treatment adherence, perhaps by creating the same sense of accountability promoted by regular office visits
Arm 3 - Initial patient consult
EXPERIMENTALParticipant will be given the medication with an electronic monitoring cap attached and will receive an initial patient consultation intervention, which will focus on the prescribed medication education and setting expectations of what to anticipate with usage of the medication
Interventions
The participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit
Participants will receive a weekly electronic text/email-based intervention that is designed to promote better adherence to treatment in addition to receiving their medication with the electronic adapter cap on it.
Participants will be given their medication with the electronic adapter cap on it and will receive an initial patient consult intervention, which will focus on medication education and setting expectations of what to anticipate with usage of the prescribed medication
Eligibility Criteria
You may qualify if:
- Adult 18 years or older
- Diagnosis of mild psoriasis with Otezla recommendation
- Non-pregnant
- English speaking
You may not qualify if:
- Under 18 years of age
- Not diagnosis of mild psoriasis
- Pregnant
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- Amgencollaborator
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (5)
Salisbury KR, Ranpariya VK, Feldman SR. Accountability in reminder-based adherence interventions: A review. Patient Educ Couns. 2022 Aug;105(8):2645-2652. doi: 10.1016/j.pec.2021.12.009. Epub 2021 Dec 15.
PMID: 34953618BACKGROUNDOkwundu N, Cardwell LA, Cline AE, Richardson IM, Feldman SR. Adherence to topical treatment can improve treatment-resistant moderate psoriasis. Cutis. 2020 Feb;105(2):89-91;E2;E3.
PMID: 32186523BACKGROUNDAlinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, Feldman SR. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017 Mar;176(3):759-764. doi: 10.1111/bjd.15085. Epub 2016 Nov 29.
PMID: 27664969BACKGROUNDWest C, Narahari S, O'Neill J, Davis S, Huynh M, Clark A, Boles A, Feldman SR. Adherence to adalimumab in patients with moderate to severe psoriasis. Dermatol Online J. 2013 May 15;19(5):18182.
PMID: 24011280BACKGROUNDYentzer BA, Wood AA, Sagransky MJ, O'Neill JL, Clark AR, Williams LL, Feldman SR. An Internet-based survey and improvement of acne treatment outcomes. Arch Dermatol. 2011 Oct;147(10):1223-4. doi: 10.1001/archdermatol.2011.277. No abstract available.
PMID: 22006146BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven R Feldman, MD, PhD
Wake Forest University Health Science
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant will not know that the electronic cap adapter is actually recording the opening of the medication bottle.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2022
First Posted
November 1, 2022
Study Start
June 1, 2025
Primary Completion
November 1, 2025
Study Completion
February 1, 2026
Last Updated
May 29, 2025
Record last verified: 2025-05