Ustekinumab Plus UVB-311nm in Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870285
• Other study ID #: Graz IRB 20-253 ex 08/09
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: March 15, 2012
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University, Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified PASI (psoriasis area and severity index)		12 months	No
Secondary	Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions		12 months	No