NCT00870285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

March 26, 2009

Last Update Submit

March 15, 2012

Conditions

Psoriasis

Keywords

PsoriasisBiologicUstekinumabUVB-311nm narrowbandphototherapyhalf-side comparison

Outcome Measures

Primary Outcomes (1)

  • Modified PASI (psoriasis area and severity index)

    12 months

Secondary Outcomes (1)

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

    12 months

Interventions

UVB 311nm radiationRADIATION

UVB-311nm radiation given 3 times a week to one randomized body-half

Also known as: narrow-band UVB radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University, Department of Dermatology

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Radiation

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Peter Wolf, MD

    Medical University of Graz, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Bioimmunotherapy

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

AU(1)