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Phase 4 N=20 Treatment

Topical Psoriasis Study for Patients Receiving Biologic Therapy

Psoriasis

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Psoriasis Severity — 4.25 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Topicort Topical Spray (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Psoriasis Treatment Center of Central New Jersey
Primary completion
Sep 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Psoriasis Severity
2.05
SECONDARY
Psoriasis Severity
2.05
SECONDARY
Psoriasis Severity
2.05
SECONDARY
Dermatology Life Quality Index
3.65

Summary

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Eligibility Criteria

Inclusion Criteria

  • Male or female adults ≥ 18 years of age.
  • Diagnosis of chronic plaque-type psoriasis.
  • Able to give written informed consent prior to performance of any study related procedures.
  • Treated with a biologic agent for a minimum of 24 weeks at baseline.
  • Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
  • 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.

Exclusion Criteria

  • >5% Body Surface Area
  • 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.
  • Malignancy or history of malignancy, except for:
  • treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
  • treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
  • 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 (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
  • Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
  • 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 Topicort Spray® as stated in the label.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02983981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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