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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761019
• Other study ID #: PRO12100308
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2013
• Last updated: September 4, 2015
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Taclonex Topical Suspension
topical medication for psoriasis

Locations

Country	Name	City	State
United States	UPMC Department of Dermatology, Falk Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. The change in this score between baseline and week 12 will be measured	12 weeks	No
Secondary	Body surface area	This is a measure of the percentage of the body involved with psoriasis	12 weeks	No
Secondary	safety	Throughout this study, adverse events and serious adverse events will be collected	12 weeks	Yes
Secondary	Patient satisfaction	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.	12 weeks	No

External Links

•   UPMC Dermatology Clinical Trials