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Ustekinumab Plus UVB-311nm in Psoriasis

This study has been completed.
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz Identifier:
First received: March 26, 2009
Last updated: March 15, 2012
Last verified: March 2012
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Resource links provided by NLM:

Further study details as provided by Peter Wolf, MD, Medical University of Graz:

Primary Outcome Measures:
  • Modified PASI (psoriasis area and severity index) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions [ Time Frame: 12 months ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00870285

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

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz 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

Keywords provided by Peter Wolf, MD, Medical University of Graz:
UVB-311nm narrowband
half-side comparison

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents processed this record on August 23, 2017