Phase 4
N=20
Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02985736 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Investigator Global Assessment (Scalp Only) — 1.59 score 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
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Global Assessment (Scalp Only) |
1.59 | — |
Summary
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
Eligibility Criteria
Inclusion Criteria
- Male or female adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type scalp psoriasis.
- IGA of mild or greater (scalp only) determined at screening
- Scalp surface area of 30% or greater determined at screening
- Able to give written informed consent prior to performance of any study related procedures.
- 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
- <30% scalp surface area
- Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
- 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 (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
- Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
- Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
- Patient received psoralen and Ultraviolet A, 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 (NCT02985736). 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.