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)

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 Overview

• Status: Completed
• Conditions: Stress; Psoriasis
• Intervention / Treatment: Device: Transdermal Electrical Neuromodulator (TEN)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Site 1
    • San Diego, California, United States, 92123
      • Site 3
    • Santa Monica, California, United States, 90404
      • Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEN 1-11 kHz; Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz)	Device: 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 Names: Thync TEN
Active Comparator: TEN 1-3 kHz; Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz)	Device: 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 Names: Thync TEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Thync Global, Inc.
• Collaborators: ethica Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): July 24, 2018
• Study Completion (Actual): July 24, 2018

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents
• Other Study ID Numbers: THY-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes