Skip to content

Primary UVB-311nm and Adalimumab in Psoriasis Patients

Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638261
Enrollment
4
Registered
2008-03-19
Start date
2008-03-31
Completion date
2011-08-31
Last updated
2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, Biologic, Adalimumab, Narrow-band UVB, phototherapy, half-side comparison

Brief summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Detailed description

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) 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.

Interventions

RADIATIONUVB-311nm

UVB-311nm radiation given 3 times a week to one randomized body-half

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Psoriasis patients who are scheduled for 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

Design outcomes

Primary

MeasureTime frame
Modified PASI (psoriasis area and severity index)12 months

Secondary

MeasureTime frame
Patient visual analogue score (VAS) for therapeutic effect12 months
Patient VAS for severity of skin lesions12 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026