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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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This is a 12-Week, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate to severe psoriasis treated with TEN. Psoriasis severity and stress levels will be measured at Weeks 0, 4, 8 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEN 1-11 kHz | Experimental | Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz) |
|
| TEN 1-3 kHz | Active Comparator | Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Electrical Neuromodulator (TEN) | Device | Thync TEN is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck (C3 to C7). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who reach PASI 50 (50% reduction in PASI score from Baseline) | Standard Psoriasis Area and Severity Index (PASI) scoring system, which incorporates erythema, induration, and scale (0-4) weighted by percentage of body surface area involvement. | Week 4, 8, and 12 |
| Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline) | Standard Psoriasis Area and Severity Index (PASI) scoring system, which incorporates erythema, induration, and scale (0-4) weighted by percentage of body surface area involvement. | Week 4, 8, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI change from Baseline | Standard Psoriasis Area and Severity Index (PASI) scoring system, which incorporates erythema, induration, and scale (0-4) weighted by percentage of body surface area involvement. | Week 4, 8, and 12 |
| IGA change from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Fremont | California | 94538 | United States | ||
| Site 3 |
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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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Standard Investigator Global Assessment (IGA) scoring system, which incorporates plaque elevation, scaling and erythema on a score of 0-5 (clear to very severe) averaged over all lesions. |
| Week 4, 8, and 12 |
| IGA Responder Rate | Proportion of Subjects with a Standard Investigator Global Assessment (IGA) score of 0 or 1. IGA incorporates plaque elevation, scaling and erythema on a score of 0-5 (clear to very severe) averaged over all lesions. | Week 4, 8, and 12 |
| DLQI change from Baseline | Dermatology Life Quality Index 10-item self-reported survey, to addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment. | Week 4, 8, and 12 |
| PQOL-12 change from Baseline | Psoriasis Quality of Life - 12 Item psoriasis-specific validated Patient Reported Outcome questionnaire, developed as part of the Koo-Menter Psoriasis Index (KMPI) in 2005, a tool to determine whether a patient with moderate to severe psoriasis is a candidate for more aggressive treatments beyond topical therapies. | Week 4, 8, and 12 |
| HADS change from Baseline | Hospital Anxiety and Depression Scale self-rated 14-item questionnaire, with seven questions related to depression (HADS-D) and seven to anxiety (HADS-A). Scoring is interpreted as follows: 0-7 points is defined as no symptoms, 8-10 points are mild symptoms, 11-14 points signify moderate symptoms, and severe symptoms are defined as having greater than 15 points. Depression and anxiety states are diagnosed when HADS-D and HADS-A scores are greater than 8 points, respectively. | Week 4, 8, and 12 |
| QVAS change from Baseline | Stress Level Quantified Visual Analogue Scale (QVAS) subjective measure of level of stress using an 11-point scale (0-10) | Week 4, 8, and 12 |
| Pruritus NRS change from Baseline | Pruritus Numerical Rating 11-point Scale (0-10) to assess subjective maximum itch intensity in the previous 24 hours | Week 4, 8, and 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Site 2 | Santa Monica | California | 90404 | United States |