Taltz in Combination With Enstilar for Psoriasis
- Registration Number
- NCT04372277
- Lead Sponsor
- Psoriasis Treatment Center of Central New Jersey
- Brief Summary
Enstilar in combination with Taltz for plaque psoriasis.
- Detailed Description
A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- 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 Criteria
-˂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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enstilar Enstilar Enstilar foam
- Primary Outcome Measures
Name Time Method Body Surface Area 0 or 1 4 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States