Primary UVB-311nm and Adalimumab in Psoriasis Patients

Not Applicable

Completed

• Conditions: Psoriasis

• Registration Number: NCT00638261
• Lead Sponsor: Medical University of Graz

Brief Summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Detailed Description

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-19
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion Criteria

• Pregnancy or lactation
• History of skin cancer
• Presence of or history of malignant skin tumors
• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Modified PASI (psoriasis area and severity index)	12 months

Secondary Outcome Measures

Name	Time	Method
Patient visual analogue score (VAS) for therapeutic effect	12 months
Patient VAS for severity of skin lesions	12 months

Trial Locations

Locations (1)

Medical University of Graz, Department of Dermatology; 🇦🇹 Graz, Austria