RECRUITING

Taltz in Combination With Enstilar for Psoriasis

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Enstilar in combination with Taltz for plaque psoriasis.

Official Title

Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients

Quick Facts

Study Start:2020-04-28

Study Completion:2021-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04372277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
* 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Jerry Bagel, MD

CONTACT

6094434500

dreamacres1@aol.com

Elise Nelson

CONTACT

6094434500

enelson@windsordermatology.com

Study Locations (Sites)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

United States

Collaborators and Investigators

Sponsor: Psoriasis Treatment Center of Central New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-28

Study Completion Date2021-03-30

Study Record Updates

Study Start Date2020-04-28

Study Completion Date2021-03-30

Terms related to this study

Additional Relevant MeSH Terms

Psoriasis