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Protocol was changed to make it easier for treating doctors. No safety concerns
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The purpose of this study is to determine the best dosing strategy when using Excimer Laser to treat plaque-type psoriasis. In this study, half of the body's psoriasis will be treated with a new dosing strategy, and the other half will be treated with the conventional method. We hope to show that the new dosing strategy will result in faster improvement of psoriasis.
This is a randomized, assessor-blinded clinical trial to determine whether a novel plaque-based dosimetry strategy can improve the speed of response to excimer laser treatment in patients with plaque psoriasis. Each patient will receive plaque-based dosing on one side of the body and conventional dosing on the contralateral side. This design is based on the assumption that psoriasis usually affects patients in a symmetric distribution (e.g., knees and elbows) and the effect of excimer laser phototherapy is limited to the treated plaque. The side of the body treated with plaque-based dosimetry will be assigned using a table of random numbers. The assessor will be blinded to the treatment group. Each patient will be treated 1-2 times per week at the discretion of the investigator for a maximum of 10 treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Dosing | Active Comparator | Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses. |
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| Plaque based dosing | Experimental | Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer laser phototherapy | Device | Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated). |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Psoriasis Area Severity Index | The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Bhutani, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Psoriasis Skin and Treatment Center | San Francisco | California | 94118 | United States |
One patient lost to follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Dosing/Plaque Based Dosing | Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses. Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Dosing/Plaque Based Dosing | Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses. Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Modified Psoriasis Area Severity Index | The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement. | The sponsor decided to stop the current trial and start a new, larger multi center sponsored study. The results were not analyzed due to termination of study. | Posted | 10 weeks |
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Adverse events were reviewed at each participant visit (once or twice weekly) for the duration of the study (total of 5 months).
No patients reported SAEs, no deaths occurred during this study, no AEs of any type was reported during this study.
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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 | Conventional Dosing/Plaque Based Dosing | Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses. Excimer laser phototherapy: Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated). |
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The sponsor decided to stop the current trial and start a new, larger multi center sponsored study. The results were not analyzed due to termination of study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Bhutani | UCSF Psoriasis and Skin Treatment Center | 4159147618 | psoriasis@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2014 | Apr 1, 2019 | Prot_SAP_000.pdf |
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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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| 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 (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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