Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis
Completed · Not applicable · Has a placebo group
Conditions studied: Psoriasis
In brief
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).
Key facts
- Study ID
- NCT02107482
- Run by
- Tufts Medical Center
- People needed
- 21
- Starts
- 2011-12-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults 18 years or older with bilateral psoriasis plaques, in general good health as determined by the Principal Investigator by medical history and physical exam.
- Able to understand consent procedure
- Able to comply with protocol activities
- Must have baseline symmetric target lesions with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12), i.e., moderate in intensity for each target.
- Target Lesion Scoring: Thickness, scaling and erythema of the plaques are rated each on a scale of 0-4. The three scores are summed. The minimum score is 0; the maximum is 12. Scores of 6 or greater are considered moderate to severe.
You may not qualify if…
- Patients less than 18 years old
- Patients not able to understand consent procedure
- Patients unable to comply with protocol activities
- Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English
- Baseline target lesions scores of less than 6
- Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity
- Patients receiving concomitant phototherapy to test sites
- Patient receiving topical medication to test sites within 2 weeks of study initiation
- Patient receiving Methotrexate, Acitretin, Cyclosporine, or other oral medications for psoriasis within 4 weeks of study initiation
- Patients receiving Etanercept (Enbrel®) within the past 2 months of study initiation
- Patients receiving Infliximab (Remicade®), Ustekinumab (Stelara®), Golimumab (Simponi®) Adalimumab (Humira®) or Alefacept (Amevive®) within the past 3 months prior to study initiation
- Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study ignition
- Systemic corticosteroid therapy within the past month
- Concurrent use of prohibited medications
Where it is running
- Dermatology Research, Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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