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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0, 2, 8, 12, and 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | Active stimulation pulsed current delivered over 15 minutes. |
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| Control Treatment | Sham Comparator | Active stimulation pulsed current (alternative frequency) delivered over 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic Nerve Modulation - Active | Device | Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck. |
| Measure | Description | Time Frame |
|---|---|---|
| BSA x sPGA average percent change from Baseline | Body Surface Area x Static Physician Global Assessment | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| sPGA change from Baseline | Static Physician Global Assessment | Week 16 |
| BSA change from Baseline | Body Surface Area | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1) | Static Physician Global Assessment | Week 16 |
Inclusion Criteria:
Exclusion Criteria:
Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic arthritis, or drug-induced psoriasis.
Subjects with plaque psoriasis on palms and soles at enrolment.
Subjects with plaque psoriasis on the back of the neck that would interfere with device placement.
Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
Other than psoriasis, history of any clinically significant (as determined by Investigator) or other major uncontrolled disease.
Psoriasis flare or rebound within 4 weeks of Visit 1 or spontaneously improving or rapidly deteriorating plaque psoriasis during that same time period, as determined by investigator.
Use of prohibited medications within the following washout periods:
Prolonged sun exposure or use of tanning booths or other source of UV radiation.
Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for entry into this study.
Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
Exposure to any other investigational drug/device within 30 days prior to study entry.
Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Fremont | California | 94538 | United States |
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| Autonomic Nerve Modulation - Control | Device | Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck. |
|
| Mean PASI change from Baseline | Psoriasis Area and Severity Index | Week 16 |
| PASI 50 | Psoriasis Area and Severity Index - 50% reduction | Week 16 |
| PASI 75 | Psoriasis Area and Severity Index - 75% reduction | Week 16 |
| PSSI change from Baseline | Psoriasis Scalp Severity Index | Week 16 |
| QVAS change from Baseline | Stress Level Quantified Visual Analogue Scale | Week 16 |
| DLQI change from Baseline | Dermatology Life Quality Index | Week 16 |
| PQOL-12 change from Baseline | Psoriasis Quality of Life - 12 Item | Week 16 |
| HADS change from Baseline | Hospital Anxiety and Depression Scale | Week 16 |
| Pruritus NRS change from Baseline | Pruritus Numerical Rating Scale | Week 16 |
| Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement) | Pruritus Numerical Rating Scale | Week 16 |
| TSQM | Treatment Satisfaction Questionnaire for Medication | Week 16 |