A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy

Study Overview
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Brief Summary
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Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. The purpose of this study is to determine if adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex topical suspension), will improve the severity of psoriasis in patients already on methotrexate or acitretin and to determine if adding this topical suspension will reduce the desire of such patients to switch to a biologic agent to treat their psoriasis.

Detailed Description
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Many patients with mild psoriasis are able to control disease symptoms with topical medications alone. There are a variety of topical options available, including corticosteroids, synthetic vitamin D3, vitamin A, coal tar, salicylic acid and a number of other products of varying efficacy. The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate to severe psoriasis vulgaris and is FDA approved for use on the skin and scalp in adults 18 years and older. This treatment combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is well tolerated and has a low rate of adverse events according to pooled safety data from 2700 patients who have used a calcipotriene/betamethasone combination in clinical trials. Calcipotriene/betamethasone topical suspension has also been shown to have a positive impact on patient quality of life, as seen in clinical trials utilizing patient reported outcomes such as the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index. Calcipotriene/betamethasone topical suspension is a therapy commonly used to treat patients with mild to moderate psoriasis. Currently, there have been no formal trials studying the efficacy of calcipotriene/betamethasone topical suspension used in conjunction with methotrexate or acitretin. In order to better understand the effectiveness of this treatment combination, we conducted a preliminary, open label, single arm prospective study to determine the benefit of adding betamethasone-calcipotriene topical suspension to ongoing systemic psoriasis therapy in subjects who do not have complete clearance of psoriasis on a single systemic agent alone.

Official Title
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A Preliminary, Open Label, Single-arm Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Taclonex Topical Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 years and older with stable plaque psoriasis of duration of at least 6 months. Subject must be currently using a stable dose, with stable disease severity, of a single non-biologic systemic psoriasis medication (methotrexate or acitretin) for at least 2 months. Subject must be planning to continue current systemic agent, and standard of care monitoring for that medication All labs required for methotrexate or acitretin will be done according to standard of care. If a woman, before entry she must be: Postmenopausal, or practicing a highly effective method of birth control Women of childbearing potential must have a negative urine pregnancy test prior to randomization Subject must be able and willing to provide written informed consent to participate. Exclusion Criteria: Non-plaque psoriasis (pustular, erythrodermic, or guttate). Use of excluded therapies: phototherapy use currently or in the 4 weeks prior to baseline, use of more than 1 systemic therapy in the 2 months prior to baseline, use of topical steroid, tar preparation, or vitamin D analog in the 4 weeks prior to baseline. Subjects who are currently taking or have taken in the past 60 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system. Subjects with any use at any time in the past of Taclonex topical suspension or Taclonex ointment Subjects who are pregnant, nursing, or plan on becoming pregnant during the course of the study. Presence of any unstable medical or psychiatric condition that, in the opinion of the investigator, could impair subject compliance. Subject has any active infection within 30 days prior to baseline. Known or suspected disorders of calcium metabolism Known or suspected severe kidney or liver disease. Known or suspected hypersensitivity to component(s) of the investigational products.

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 |
| --- | --- |
| Other: Taclonex topical suspension<br>Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks | Drug: Taclonex Topical Suspension<br>* topical medication for psoriasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment | This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Surface Area | This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12. | 12 weeks | 
| Safety | Throughout this study, adverse events and serious adverse events will be collected | 12 weeks | 
| Patient Satisfaction | • Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: very satisfied, satisfied, somewhat disappointed or very disappointed. For measurement very satisfied=4, satisfied=3, somewhat disappointed=2 and very disappointed=1. We will determine the mean satisfaction of all patients at week 12. | 12 weeks | 
| Desire to Change to Another Systemic Therapy | We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, Taclonex, Acitretin, Methotrexate