A Randomized, Prospective, Sham-Controlled Study of Localized Narrow-Band UVB Phototherapy in the Treatment of Plaque Psoriasis
August 2014 | Volume 13 | Issue 8 | Original Article | 922 | Copyright © 2014
Adriane A. Levin BA,a,b Saud Aleissa MD,a Nicole Dumont,a Francisca Martinez,a Courtney Donovan RN,a
Shiu-chung Au MD,a Afnan Hasanain MD,a and Alice B. Gottlieb MD PhDa,c
aTufts Medical Center, Department of Dermatology, Boston, MA
bBoston University School of Medicine, Boston, MA
cTufts University School of Medicine, Boston, MA
IMPORTANCE: UV phototherapy remains a useful and frequently employed treatment for chronic plaque psoriasis. In those patients with
plaque body surface area less than 10%, targeted treatment is the safest and most effective modality.
OBJECTIVE: We aimed to evaluate the efficacy of the Levia® localized NB-UVB phototherapy machine in the treatment of patients with symmetrical psoriatic lesions.
DESIGN: We performed a prospective, double-blinded, sham-treatment controlled study of this device beginning March 2012 through April 2014.
SETTING: a comprehensive dermatology clinic in the northeastern United States.
PARTICIPANTS: 21 subjects with chronic plaque psoriasis.
INTERVENTIONS: Each patient had one lesion randomized to receive the Levia treatment and one lesion (the control) treated with visible light. Treatment was administered three times a week for twelve weeks. Target lesion score (TLS), a rating of 0-4 each of erythema, scaling, and thickness, was measured biweekly by a blinded assessor, and visual analogue scale of pruritus was recorded by subjects.
MAIN OUTCOMES AND MEASURES: The primary outcome, formulated prior to study initiation, was the percentage of lesions achieving clear or almost clear TLS after 12 weeks of treatment. Secondary endpoints included changes in target lesion pruritus VAS, percentage improvement in TLS, and the percentage of subjects achieving 50% improvement in TLS (TLS-50).
RESULTS: The primary endpoint, TLS of three or less, was not achieved (P=0.118), but the secondary endpoints of percentage improvement in TLS (P=0.043) and TLS-50 (P=0.0195) were significantly superior in treated compared to sham-treated lesions. Percentage improvement in pruritus VAS was not significant (P=0.0565).
CONCLUSIONS AND RELEVANCE: This device was found to be efficacious, though not necessarily to the point of clearance, in the treatment of psoriasis over a 12-week period.
TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT02107482, http://clinicaltrials.gov/show/NCT02107482
J Drugs Dermatol. 2014;13(8):922-926.
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Psoriasis is a chronic autoimmune disease that affects 2-3% of adults.1 Despite newer oral and injectable systemic treatment options, phototherapy remains prevalent in disease therapy. Ultraviolet-B (UVB) phototherapy involves the use of artificial UVB radiation without exogenous photosensitizers. A pivotal study in the field of phototherapy reported that 313nm is the optimal wavelength for the treatment of psoriasis; longer wavelengths provided no therapeutic advantage and shorter wavelengths led to greater burning.2 Nevertheless, broadband UVB (BB-UVB) is still widely in use. Additionally, although more than 80% of patients with psoriasis have a BSA<10%,3 whole body irradiation is frequently employed in treatment. Recent guidelines recommend the use of targeted UVB phototherapy for children and adults with a BSA<10%.4 Psoriatic plaques can tolerate higher UVB doses than can normal skin, therefore higher doses can be applied when diseased areas are specifically targeted.5 Localized treatment additionally benefits patients with flexural involvement for whom full-body treatment offers less dramatic improvement.5
In this study, we aimed to evaluate the efficacy of FDA-approved Levia® localized NB-UVB treatment in patients with plaque-type psoriasis. Patients with symmetrical lesions were randomized to have one site treated with NB-UVB and the other site treated with sham visible light administered by on-site phototherapists. Treatments were administered three times a week for twelve weeks. This is the first sham-treatment controlled, double blind study of this device. One preceding non-blinded, non-randomized pilot study of a precursor, broad-band UVB unit exists in the literature.8