RecruitingPhase 4NCT04372277
Taltz in Combination With Enstilar for Psoriasis
Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients
Sponsor
Psoriasis Treatment Center of Central New Jersey
Enrollment
25 participants
Start Date
Apr 28, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
Enstilar in combination with Taltz for plaque psoriasis.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria10
- ˂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.
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Interventions
DRUGEnstilar
topical Enstilar foam
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04372277
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