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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levia Narrow Band UVB | Active Comparator | Levia Narrow Band UVB dosing 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. |
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| Levia sham/visible-light source | Sham Comparator | the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levia Narrow Band UVB | Device | The device's spectral output is is Narrow Band UVB (NB-UVB) (NB-Levia): 308-312 nm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Change in Target Lesion Score | 12 weeks | |
| Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12 | 12 weeks |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice b Gottlieb, MD, PhD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research, Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25116969 | Derived | Levin AA, Aleissa S, Dumont N, Martinez F, Donovan C, Au SC, Hasanain A, Gottlieb AB. A randomized, prospective, sham-controlled study of localized narrow-band UVB phototherapy in the treatment of plaque psoriasis. J Drugs Dermatol. 2014 Aug;13(8):922-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants - Levia Narrow Band UVB | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | percentage of lesions changed | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| burn | Skin and subcutaneous tissue disorders | skin burn | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Dumont | Tufts Medical Center | 617 636 7462 | ndonovan1@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Levia sham/visible-light source | Device | the light spectrum is in the range of 400-700nm, the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum. |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Secondary | The Percentage of Change in Target Lesion Score | Posted | Mean | Standard Deviation | percentage of change in TLS | 12 weeks |
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| Secondary | Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12 | Posted | Mean | Standard Deviation | Percent Change in Target Lesion Pruritus | 12 weeks |
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| 0 |
| 21 |
| 8 |
| 21 |
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