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Ustekinumab Plus UVB-311nm in Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00870285
First received: March 26, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.


Condition Intervention
Psoriasis
 Radiation: UVB 311nm radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Modified PASI (psoriasis area and severity index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: UVB 311nm radiation
    UVB-311nm radiation given 3 times a week to one randomized body-half
    Other Name: narrow-band UVB radiation
Detailed Description:

Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to < 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Psoriasis patients who receive treatment with Ustekinumab

Exclusion Criteria:

  • Age below 18 years
  • Pregnancy or lactation
  • History of malignant melanoma
  • History of invasive squamous cell carcinoma of the skin
  • Dysplastic melanocytic nevus syndrome
  • Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
  • Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
  • Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
  • General poor health status
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870285

Locations
Austria
Medical University, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria
  More Information

No publications provided

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00870285     History of Changes
Other Study ID Numbers: Graz IRB 20-253 ex 08/09
Study First Received: March 26, 2009
Last Updated: March 15, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Psoriasis
Biologic
Ustekinumab
 UVB-311nm narrowband
phototherapy
half-side comparison

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

ClinicalTrials.gov processed this record on May 19, 2013