Phase 4
N=20
Topical Psoriasis Study for Patients Receiving Biologic Therapy
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02983981 ↗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
| Outcome | Result | p-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.
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.