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

NCT01761019 | Completed Phase 4 Results DMC

• 1 other identifier: PRO12100308
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; Taclonex; Acitretin; Methotrexate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Body Surface Area

  12 weeks

• Safety

  12 weeks

• Patient Satisfaction

  12 weeks

• Desire to Change to Another Systemic Therapy

  12 weeks

Study Arms (1)

Taclonex topical suspension

OTHER

Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks

Drug: Taclonex Topical Suspension

Interventions

Taclonex Topical Suspension DRUG

topical medication for psoriasis

Taclonex topical suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• LEO Pharma: collaborator

Study Sites (1)

UPMC Department of Dermatology, Falk Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 27462386 DERIVED

Related Links

• UPMC Dermatology Clinical Trials

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The greatest limitation of this study was the small sample size. Other study limitations include the open label, non-randomized design and absence of a placebo arm.

Results Point of Contact

• Title: Laura K. Ferris, MD, PhD
• Organization: Department of Dermatology, University of Pittsburgh School of Medicine

ferrlk@upmc.edu

412-647-2013

Study Officials

• Laura Ferris, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 21, 2016
• Results First Posted: September 21, 2016

Record last verified: 2016-08

Locations

US (1)