Ustekinumab Plus UVB-311nm in Psoriasis

Medical University of Graz

Status

Completed

Conditions

Psoriasis

Treatments

Radiation: UVB 311nm radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00870285

Graz IRB 20-253 ex 08/09

Details and patient eligibility

About

Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.

Full description

Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years
Psoriasis patients who receive treatment with Ustekinumab

Exclusion criteria

Age below 18 years
Pregnancy or lactation
History of malignant melanoma
History of invasive squamous cell carcinoma of the skin
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