12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN
NCT ID: NCT03511755
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2018-03-12
2018-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TEN 1-11 kHz
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz)
Transdermal Electrical Neuromodulator (TEN)
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).
TEN 1-3 kHz
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz)
Transdermal Electrical Neuromodulator (TEN)
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).
Interventions
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Transdermal Electrical Neuromodulator (TEN)
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate (\>3 to \<10% BSA) with a PASI of at least 6 and less than 12 or severe (≥10% BSA) plaque psoriasis with a minimal PASI score of 12.
* Subject diagnosed with psoriasis at least 6 months prior to entering the study.
* Subjects who have received treatment in the past for psoriasis and are currently untreated or subjects who are on stable treatment for psoriasis that is expected to remain unchanged throughout the entire duration.
* Subjects who have not received psoriasis treatments in the past should be stable in their disease for the last 4 weeks.
Exclusion Criteria
* Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
* Unstable psoriasis or unstable treatment of psoriasis over the entire duration of the study.
* Subjects with moderate psoriasis are not allowed to use concurrent systemic therapies for psoriasis (i.e., phototherapy, orals, biologics, etc.). Topical medications are allowed;
* Subjects with severe psoriasis are allowed to use any concurrent therapy for psoriasis, provided that disease state is stable for ≥2 months and they meet minimum PASI requirements.
* Cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.
18 Years
ALL
No
Sponsors
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ethica Clinical Research Inc.
INDUSTRY
Thync Global, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 1
Fremont, California, United States
Site 3
San Diego, California, United States
Site 2
Santa Monica, California, United States
Countries
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Other Identifiers
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THY-002
Identifier Type: -
Identifier Source: org_study_id
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