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Trial record 8 of 46 for:    Taclonex | psoriasis

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

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ClinicalTrials.gov Identifier: NCT01761019
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Laura Ferris, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Results First Submitted Date  ICMJE September 17, 2015
Results First Posted Date  ICMJE September 21, 2016
Last Update Posted Date September 21, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Investigator Global Assessment [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Investigator Global Assessment [ Time Frame: 12 weeks ]
This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject. The change in this score between baseline and week 12 will be measured
Change History Complete list of historical versions of study NCT01761019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Body Surface Area [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    Throughout this study, adverse events and serious adverse events will be collected
  • Patient Satisfaction [ Time Frame: 12 weeks ]
    • 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 [ Time Frame: 12 weeks ]
    We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Body Surface Area [ Time Frame: 12 weeks ]
    This is a measure of the percentage of the body involved with psoriasis
  • Safety [ Time Frame: 12 weeks ]
    Throughout this study, adverse events and serious adverse events will be collected
  • Patient satisfaction [ Time Frame: 12 weeks ]
    • We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
    • Subject satisfaction: We also ask subjects for their level of satisfaction with current treatment at baseline and week 12. They will be given the following options: "very satisfied", "satisfied", "somewhat disappointed" or "very disappointed". We will then determine the effect of adding Taclonex topical suspension to a single systemic agent on subject satisfaction by calculating percentage of subjects who were more satisified, less satisfied, or had no change in their level of satisfaction with their treatment regimen at baseline vs week 12.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Official Title  ICMJE A Preliminary, Open Label, Single-arm Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Taclonex Topical Suspension
topical medication for psoriasis
Study Arms  ICMJE Taclonex topical suspension
Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Intervention: Drug: Taclonex Topical Suspension
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
15
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761019
Other Study ID Numbers  ICMJE PRO12100308
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura Ferris, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE LEO Pharma
Investigators  ICMJE
Principal Investigator: Laura Ferris, MD, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP