Trial Outcomes & Findings for Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis (NCT NCT02107482)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-03-31

Participant milestones
Measure	All Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	All Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
Overall Study inconveinence	2
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1

Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis

Baseline characteristics by cohort
Measure	All Participants - Levia Narrow Band UVB n=21 Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	48.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized white	20 participants n=5 Participants
Race/Ethnicity, Customized African american	1 participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

Timeframe: 12 weeks

Outcome measures
Measure	All Participants n=21 Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12 Levia Narrow Band UVB	47.6 percentage of lesions changed
The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12 Levia Sham	33.3 percentage of lesions changed

Timeframe: 12 weeks

Outcome measures
Measure	All Participants n=21 Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
The Percentage of Change in Target Lesion Score Levia Narrow Band UVB	47 percentage of change in TLS Standard Deviation 0.8
The Percentage of Change in Target Lesion Score Levia Sham	29 percentage of change in TLS Standard Deviation 0.8

Timeframe: 12 weeks

Outcome measures
Measure	All Participants n=21 Participants Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12 Levia Narrow baned UVB	62 Percent Change in Target Lesion Pruritus Standard Deviation 0.8
Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12 Levia Sham	27 Percent Change in Target Lesion Pruritus Standard Deviation 0.8

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Participants n=21 participants at risk Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, 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. The same subject will have a second target lesion treated with the Sham Comparator.
Skin and subcutaneous tissue disorders burn	38.1% 8/21 • Number of events 19 • 12 weeks

Tufts Medical Center

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