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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
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).
Site 1
Fremont, California, United States
Site 3
San Diego, California, United States
Site 2
Santa Monica, California, United States
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.
Time frame: 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.
Time frame: Week 4, 8, and 12
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.
Time frame: Week 4, 8, and 12
IGA change from Baseline
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Week 4, 8, and 12