Psoriasis Clinical Trial
Official title:
Bilateral Comparator, Sham-Light Source Controlled, Assessor Blinded Clinical Trial of Localized Narrow Band-Ultraviolet B (NB-UVB) (Levia®) Treatment for Plaque-type Psoriasis
The purpose of the study is to test the effect of a localized narrow band ultraviolet (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance of psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy device is cleared by the U.S Food and Drug Administration (FDA).
This will be an ascending dose study with treatments three times per week, initial treatment
dose and increasing regimen is adjusted according to the subject skin type. A suggested
treatment regimen schedule provided from Lerner Medical Devices, Inc:
For subjects with skin type I: starting dose of 195 mj/cm2, for subjects with skin type II:
starting dose of 330 mj/cm2, for subjects with skin type III: starting dose of 390 mj/cm2,
for subjects with skin type IV: starting dose of 495 mj/cm2, for subjects with skin type V:
starting dose of 525 mj/cm2, for subjects with skin type VI: starting dose of 600 mj/cm2.
The dose will be increased by 15% with each treatment, as long as there are no side effects
with treatment such as burning or redness.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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