Enstilar in combination with Taltz for plaque psoriasis.
Full Title of Study: “Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 1, 2021
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%.
- Drug: Enstilar
- topical Enstilar foam
Arms, Groups and Cohorts
- Experimental: Enstilar
- Enstilar foam
Clinical Trial Outcome Measures
- Body Surface Area 0 or 1
- Time Frame: 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.
Participating in This Clinical Trial
- 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.
-˂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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Psoriasis Treatment Center of Central New Jersey
- Eli Lilly and Company
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Jerry Bagel, MD, 6094434500, firstname.lastname@example.org
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