Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Study Overview
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Brief Summary
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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

Detailed Description
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All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)

Official Title
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An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Topicort Topical Spray


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label<br> | Drug: Topicort Topical Spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (scalp only) | Scalp psoriasis severity scale | 16 weeks | 
| Psoriasis Scalp Severity Index | Scalp psoriasis severity scale | 16 weeks | 
| Scalp Surface Area | Measures % of scalp affected with psoriasis | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body surface area multiplied by physician's global assessement | measures psoriasis severity improvement | 16 weeks | 
| scalpdex questionnaire | patient reported outcome | 16 weeks | 
| visual analog scale | measures subject assessment of pain | 16 weeks |