Etanercept Plus UVB-311nm Phototherapy in Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Radiation: UVB-311nm radiation; Other: No treatment

• Registration Number: NCT00550030
• Lead Sponsor: Medical University of Graz

Brief Summary

Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.

Detailed Description

Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to \< 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality 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: 2006-08
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-26
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater

Exclusion Criteria

• Pregnancy or lactation
• 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

Arm && Interventions

Group	Intervention	Description
left/right	No treatment	half-body comparison
left/right	UVB-311nm radiation	half-body comparison

Primary Outcome Measures

Name	Time	Method
Reduction of PASI (psoriasis activity score index)	prospective

Secondary Outcome Measures

Name	Time	Method
Patient disease and life quality score	prospective

Trial Locations

Locations (1)

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