Clinical trial NCT00550030: Etanercept Plus UVB-311nm Phototherapy in Psoriasis
Official title: Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
UVB radiation
Biologics
Etanercept
PASI
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of PASI (psoriasis activity score index)
timeFrame: prospective
Secondary outcomes:
measure: Patient disease and life quality score
timeFrame: prospective
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Dermatology
Study officials:
affiliation: Dept. of Dermatology, Medical University of Graz, Graz, Austria
name: Peter Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References: