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Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment


N/A
18 Years
N/A
Not Enrolling
Both
Psoriasis

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Trial Information

Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction of PASI (psoriasis activity score index)

Outcome Time Frame:

prospective

Safety Issue:

No

Principal Investigator

Peter Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Dermatology, Medical University of Graz, Graz, Austria

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

17-257 ex 05/06

NCT ID:

NCT00550030

Start Date:

August 2006

Completion Date:

December 2010

Related Keywords:

  • Psoriasis
  • Psoriasis
  • UVB radiation
  • Biologics
  • Etanercept
  • PASI
  • Psoriasis

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