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Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.
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Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrowband Ultraviolet B (TL-01UVB) Therapy | Active Comparator | treatments - 3x weekly for 15 months |
|
| Topical Psoralen plus ultraviolet A (PUVA) | Active Comparator | Treatments - 3x weekly for 15 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrowband Ultraviolet B (TL-01UVB) Therapy | Procedure |
| ||
| Topical Psoralen plus ultraviolet A (PUVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatments required to reach clearance | Baseline to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures) | Baseline to 15 months | |
| Change in global score | Baseline to 15 months | |
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Inclusion Criteria:
Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.
Exclusion Criteria:
Age <18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
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| Name | Affiliation | Role |
|---|---|---|
| Mark D. Davis, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Procedure |
|
| Number of patients reaching clearance |
| Baseline to 15 months |
| Adverse effects | Baseline to 15 months |
| Number of days in remission | Baseline to 15 months |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D005363 | Ficusin |
| ID | Term |
|---|---|
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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