Enstilar in Combination With Biologic Agents

Study Overview
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Brief Summary
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Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.

Detailed Description
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A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Official Title
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An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Enstilar 0.005%-0.064% Topical Foam


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 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. 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 Enstilar® as stated in the label.

Ages Eligible for Study
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Minimum Age: 18 Years

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 Enstilar<br>open label | Drug: Enstilar 0.005%-0.064% Topical Foam<br>* Topical foam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy | pga x bsa | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment | PGA | 16 weeks | 
| Body Surface area | BSA | 16 weeks | 
| dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire | satisfaction determined by patient reported outcomes | 16 weeks |