Taltz in Combination With Enstilar for Psoriasis

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    Psoriasis Treatment Center of Central New Jersey
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Updated on 5 August 2020
See if I qualify
vasectomy
tubal ligation
cervical cap
plaque psoriasis
hormonal contraception
psoriasis
contraceptive sponge
enstilar
intrauterine device (iud)
taltz

Summary

Enstilar in combination with Taltz for plaque psoriasis.

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%.

Details
Condition Psoriasis
Age 18years - 100years
Treatment Enstilar
Clinical Study IdentifierNCT04372277
SponsorPsoriasis Treatment Center of Central New Jersey
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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

% 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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