Enstilar in Combination With Biologic Agents

Completed · Phase 4

Conditions studied: Psoriasis

In brief

Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.

Key facts

Study ID

NCT03080545

Run by

Psoriasis Treatment Center of Central New Jersey

People needed

25

Starts

2017-05-01

Expected to finish

2017-10-30

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adults ≥ 18 years of age.
• Diagnosis of chronic plaque-type psoriasis.
• Able to give written informed consent prior to performance of any study related procedures.
• Treated with a biologic agent for a minimum of 24 weeks at baseline.
• Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
• 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.

You may not qualify if…

• >5% Body Surface Area
• 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 (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
• Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
• 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.

Where it is running

• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States

Full record on ClinicalTrials.gov

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