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Ustekinumab Plus UVB-311nm in Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
UVB 311nm radiation
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Biologic, Ustekinumab, UVB-311nm narrowband, phototherapy, half-side comparison

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University, Department of Dermatology

Outcomes

Primary Outcome Measures

Modified PASI (psoriasis area and severity index)

Secondary Outcome Measures

Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions

Full Information

First Posted
March 26, 2009
Last Updated
March 15, 2012
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00870285
Brief Title
Ustekinumab Plus UVB-311nm in Psoriasis
Official Title
Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Biologic, Ustekinumab, UVB-311nm narrowband, phototherapy, half-side comparison

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
UVB 311nm radiation
Other Intervention Name(s)
narrow-band UVB radiation
Intervention Description
UVB-311nm radiation given 3 times a week to one randomized body-half
Primary Outcome Measure Information:
Title
Modified PASI (psoriasis area and severity index)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
Organizational Affiliation
Medical University of Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University, Department of Dermatology
City
Graz
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

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Ustekinumab Plus UVB-311nm in Psoriasis

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