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Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab


N/A
18 Years
N/A
Open (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 After Partial Remission to Treatment With Adalimumab


Patients with moderate to severe psoriasis who have received treatment with adalimumab
(loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a
PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and
UVB-311nm phototherapy is added at 6 weeks or thereafter one 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, visual analogue score (VAS)
patient score for therapeutic response, and VAS patient score 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.


Inclusion Criteria:



- Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Modified PASI (psoriasis area and severity index)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Peter Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Graz, Austria

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

19-133 ex 07/08

NCT ID:

NCT00638469

Start Date:

March 2008

Completion Date:

December 2013

Related Keywords:

  • Psoriasis
  • Psoriasis
  • Biologic
  • adalimumab
  • narrowband UVB
  • phototherapy
  • half-side comparison
  • Psoriasis

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