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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Pittsburgh
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01761019
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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, 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.


Condition Intervention Phase
Psoriasis
Drug: Taclonex Topical Suspension
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Investigator Global Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Body surface area [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is a measure of the percentage of the body involved with psoriasis

  • safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Throughout this study, adverse events and serious adverse events will be collected

  • Patient satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • 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 satisfied, less satisfied, or had no change in their level of satisfaction with their treatment regimen at baseline vs week 12.


Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Taclonex topical suspension
Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Drug: Taclonex Topical Suspension
topical medication for psoriasis
Other Name: Taclonex Topical Suspension

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761019

Locations
United States, Pennsylvania
UPMC Department of Dermatology, Falk Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laura Ferris, MD,PhD    412-647-9287    dermtrials@upmc.edu   
Principal Investigator: Laura K Ferris, MD, PhD         
Sub-Investigator: Erine Kupetsky, DO         
Sponsors and Collaborators
University of Pittsburgh
LEO Pharma
Investigators
Principal Investigator: Laura Ferris, MD, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01761019     History of Changes
Other Study ID Numbers: PRO12100308
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
psoriasis
Taclonex
Acitretin
Methotrexate

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014