Recruiting

Taltz & Enstilar

Sponsor:

Psoriasis Treatment Center of Central New Jersey

Code:

NCT04372277

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enstilar

Study Details

Brief summary:

Enstilar in combination with Taltz for plaque psoriasis.

Conditions

Psoriasis

Study ID

NCT04372277

Start date

Apr 28, 2020

Status verified date

Apr, 2020

Completion date

Mar 30, 2021

Anticipated

Primary completion date

Mar 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enstilar

Enstilar foam

Interventions

Enstilar

topical Enstilar foam

Primary outcome measure

  • Body Surface Area 0 or 1 [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jerry Bagel, MD

6094434500dreamacres1@aol.com

Elise Nelson

6094434500enelson@windsordermatology.com

Locations

Psoriasis Treatment Center of Central New Jersey

Recruiting

East Windsor, New Jersey, United States, 08520

Contacts

Elise Nelson

609-443-4500enelson@windsordermatology.com

Principal Investigator:

Jerry Bagel, MD

More Information

Sponsor

Psoriasis Treatment Center of Central New Jersey

Last update posted

May 4, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Treatment Center of Central New Jersey on 2020-05-04.