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This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this 6 weeks study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-treatment Control | No Intervention | Control arm will not have any intervention | |
| Occlusive Dressing | Active Comparator | An off-the-shelf dressing occlusive dressing will be used as an active comparator. |
|
| Luma Light | Active Comparator | A NBUVB light will be used as an active comparator. |
|
| Luma Light System | Experimental | The experimental arm will be a combination of an occlusive dressing and NBUVB light. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luma Light System | Device | The Luma Light System combines a NBUVB light with an occlusive dressing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Plaque Assessment | Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling. | 6 weeks |
| Local Skin Reactions | Tolerability will be evaluated through assessment of selected local signs and symptoms at the article-application site: Burning/stinging, pain and pruritus. Each sign or symptom will be graded at Baseline and each subsequent visit using a 0-3 scale (0 = none, 1 = mild, 2 = moderate, or 3 = severe). | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liza Marie | Contact | 707-755-3946 | liza@redwoodfamilyderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redwood Family Dermatology | Recruiting | Santa Rosa | California | 95403 | United States |
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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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| ID | Term |
|---|---|
| D009779 | Occlusive Dressings |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| Luma Light | Device | NBUVB light |
|
| Occlusive Dressing | Device | Off-the-shelf occlusive dressing |
|