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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

Must not have

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

Select...

I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

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

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

Primary study objectives

Medication Adherence Outlier

Secondary study objectives

Difference of Efficacy among high adherent subjects

Difference of Safety among low adherent subjects

Awards & Highlights

No Placebo-Only Group

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

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

0 / 2Eligibility criteria met