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Small Molecule

Adherence Strategies + Otezla for Psoriasis

Phase < 1
Waitlist Available
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
Adult 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

Study Summary

This trial showed that most with limited psoriasis have poor adherence to topical treatments, leading to larger impacts on their lives.

Who is the study for?
This trial is for adults over 18 with a mild psoriasis diagnosis who have been recommended Otezla. Participants must speak English and not be pregnant to qualify.Check my eligibility
What is being tested?
The study tests if reminder texts or extended consultations improve adherence to the psoriasis medication Otezla, compared to standard care without these interventions.See study design
What are the potential side effects?
Otezla may cause side effects like diarrhea, nausea, headache, upper respiratory tract infection, vomiting, and abdominal pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication Adherence Outlier
Secondary outcome measures
Difference of Efficacy among high adherent subjects
Difference of Safety among low adherent subjects

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3 - Initial patient consultExperimental Treatment1 Intervention
Participant 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
Group II: Arm 2 - Reminder textExperimental Treatment1 Intervention
Participant 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
Group III: Arm 1 - Standard of CareActive Control3 Interventions
Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,123 Total Patients Enrolled
12 Trials studying Psoriasis
919 Patients Enrolled for Psoriasis
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,604 Total Patients Enrolled
76 Trials studying Psoriasis
116,426 Patients Enrolled for Psoriasis
Steven R Feldman, MD, PhDPrincipal InvestigatorWake Forest University Health Science
14 Previous Clinical Trials
519 Total Patients Enrolled
4 Trials studying Psoriasis
127 Patients Enrolled for Psoriasis

Media Library

Otezla (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05601492 — Phase < 1
Psoriasis Research Study Groups: Arm 1 - Standard of Care, Arm 2 - Reminder text, Arm 3 - Initial patient consult
Psoriasis Clinical Trial 2023: Otezla Highlights & Side Effects. Trial Name: NCT05601492 — Phase < 1
Otezla (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601492 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors over 75 years of age being considered for participation in this trial?

"This clinical study is seeking adult participants aged 18 and over, yet under 85."

Answered by AI

Who has been cleared to participate in this medical investigation?

"This research endeavour seeks to enrol 84 adults aged 18 or over, with mild psoriasis that has been recommended for Otezla treatment. Additionally, eligible participants must be non-pregnant and proficient in English."

Answered by AI

Is enrollment for this clinical trial currently available?

"A glance at clinicaltrials.gov reveals that this particular trial, first publicized on January 1st 2023 and last amended November 28th 2022, is not currently seeking participants. However, there are 168 other experiments accepting patients right now."

Answered by AI
Recent research and studies
British Journal of DermatologyJournal
Long-term Adherence to Topical Psoriasis Treatment Can Be Abysmal: A 1-year Randomized Intervention Study Using Objective Electronic Adherence Monitoring
Alinia, H., S. Moradi Tuchayi, J.A. Smith, I.M. Richardson, N. Bahrami, S.C. Jaros, L.F. Sandoval, et al.. 2016. “Long-term Adherence to Topical Psoriasis Treatment Can Be Abysmal: A 1-year Randomized Intervention Study Using Objective Electronic Adherence Monitoring”. British Journal of Dermatology. Wiley. doi:10.1111/bjd.15085.
clinicaltrials.govStudy
Adherence to Otezla
2024. "Adherence to Otezla". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05601492.
All > Psoriasis > Plaque Psoriasis
~56 spots leftby Dec 2024
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