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Completed

NCT Number: NCT00870285

Ustekinumab Plus UVB-311nm in Psoriasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University, Department of Dermatology

Graz, A-8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UVB 311nm radiation

Radiation

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

Other names: narrow-band UVB radiation

Primary outcomes

  1. Modified PASI (psoriasis area and severity index)

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 27, 2009
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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