Taltz and Enstilar for Psoriasis

This study is looking at how well a combination of two treatments, Taltz and Enstilar foam, works for people with plaque psoriasis. You might be able to join if you are an adult aged 18 or older, have plaque psoriasis affecting 3% to 8% of your body, and have already been using Taltz for at least 24 weeks. The researchers want to see if adding Enstilar foam helps reduce the amount of psoriasis on your body (Body Surface Area) to 0 or 1 after 4 weeks. The study plans to enroll 25 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a single-center study planning to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 4 weeks, which suggests follow-up for at least that duration.

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NCT04372277

Taltz in Combination With Enstilar for Psoriasis

Recruiting
PHASE4Ages 18+InterventionalTreatment
Psoriasis Treatment Center of Central New Jersey
~25 participants
Updated 2020-05-04 on ClinicalTrials.gov
What's tested:Enstilar

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Surface Area 0 or 1
Measured over 4 weeks
Psoriasis
1 sites across 1 states
New Jersey1

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Eligibility criteria

Inclusion

Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Body Surface Area between 3%-8%.
Patient has been treated with Taltz for a minimum of 24 weeks
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
Able and willing to give written informed consent prior to performance of any study-related procedures.

Exclusion

˂3% or \>8% BSA
Patient not receiving Taltz, or receiving Taltz \<24 weeks
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
Patient received UVB phototherapy within 2 weeks of Baseline.
Patient received PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
  • Body Surface Area 0 or 14 weeks

    Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.