Ustekinumab Plus UVB-311nm in Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870285
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Radiation: UVB 311nm radiation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

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

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 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