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

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
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
NCT ID
NCT00870285
First Posted
March 26, 2009
Last Updated
March 15, 2012
Sponsor
Medical University of Graz
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
Learn more about this trial
Ustekinumab Plus UVB-311nm in Psoriasis
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