Back to resultsA Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Taclonex Topical Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, Taclonex, Acitretin, Methotrexate
Eligibility Criteria
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.
Sites / Locations
- UPMC Department of Dermatology, Falk Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Taclonex topical suspension
Arm Description
Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Safety
Throughout this study, adverse events and serious adverse events will be collected
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.
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.
Full Information
NCT ID
NCT01761019
First Posted
January 2, 2013
Last Updated
August 1, 2016
Sponsor
University of Pittsburgh
Collaborators
LEO Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01761019
Brief Title
A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Official Title
A Preliminary, Open Label, Single-arm Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
LEO Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, Taclonex, Acitretin, Methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taclonex topical suspension
Arm Type
Other
Arm Description
Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Taclonex Topical Suspension
Intervention Description
topical medication for psoriasis
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body Surface Area
Description
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.
Time Frame
12 weeks
Title
Safety
Description
Throughout this study, adverse events and serious adverse events will be collected
Time Frame
12 weeks
Title
Patient Satisfaction
Description
• 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.
Time Frame
12 weeks
Title
Desire to Change to Another Systemic Therapy
Description
We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Ferris, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Department of Dermatology, Falk Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27462386
Citation
Ferris LK, Kupetsky E, Houston NA. A Preliminary, Open Label, Single-arm Study of Calcipotriene/Betamethasone Topical Suspension as a Supplement to Non-biologic Systemic Therapy for Psoriasis. J Clin Aesthet Dermatol. 2016 Apr;9(4):33-8. Epub 2016 Apr 1.
Results Reference
derived
Links:
URL
http://www.upmc.com/Services/dermatology/department-of-derm/clinical-trials/Pages/clinical-trials.aspx
Description
UPMC Dermatology Clinical Trials
Learn more about this trial
A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
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