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12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN | Clinical Trials | Clareo Health

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12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN

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 Using Transdermal Electrical Neurosignaling (TEN)

NCT03511755•Thync Global, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatient, male or female of any race, 18 years of age or older.
•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

•Guttate, erythrodermic, or pustular psoriasis subtypes.
•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.

Locations (3)

Site 1

Fremont, California, United States

Site 3

San Diego, California, United States

Site 2

Santa Monica, California, United States

Key Dates

Start Date

March 12, 2018

Primary Completion Date

July 24, 2018

Completion Date

July 24, 2018

Last Updated

August 21, 2018

Enrollment

ACTUAL participants

Conditions

PsoriasisStress

Interventions

Transdermal Electrical Neuromodulator (TEN)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN

Inclusion Criteria

Exclusion Criteria

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