Psoriasis
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICELevia Narrow Band UVB
The device's spectral output is is Narrow Band UVB (NB-UVB) (NB-Levia): 308-312 nm
DEVICELevia sham/visible-light source
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.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | inconveinence | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Participants - Levia Narrow Band UVB |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 48.5 years |
| Race/Ethnicity, Customized African american | 1 participants |
| Race/Ethnicity, Customized white | 20 participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
Secondary
Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
Secondary
The Percentage of Change in Target Lesion Score
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | The Percentage of Change in Target Lesion Score | Levia Narrow Band UVB | 47 percentage of change in TLS | Standard Deviation 0.8 |
| All Participants | The Percentage of Change in Target Lesion Score | Levia Sham | 29 percentage of change in TLS | Standard Deviation 0.8 |