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

Primary Purpose

Psoriasis, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transdermal Electrical Neuromodulator (TEN)
Sponsored by
Thync Global, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site 1
  • Site 3
  • Site 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEN 1-11 kHz

TEN 1-3 kHz

Arm Description

Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz)

Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
QVAS change from Baseline
Stress Level Quantified Visual Analogue Scale (QVAS) subjective measure of level of stress using an 11-point scale (0-10)
Pruritus NRS change from Baseline
Pruritus Numerical Rating 11-point Scale (0-10) to assess subjective maximum itch intensity in the previous 24 hours

Full Information

First Posted
April 3, 2018
Last Updated
August 20, 2018
Sponsor
Thync Global, Inc.
Collaborators
ethica Clinical Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03511755
Brief Title
12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thync Global, Inc.
Collaborators
ethica Clinical Research Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEN 1-11 kHz
Arm Type
Experimental
Arm Description
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz)
Arm Title
TEN 1-3 kHz
Arm Type
Active Comparator
Arm Description
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz)
Intervention Type
Device
Intervention Name(s)
Transdermal Electrical Neuromodulator (TEN)
Other Intervention Name(s)
Thync TEN
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of subjects who reach PASI 50 (50% reduction in PASI score from Baseline)
Description
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
Title
Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)
Description
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
Secondary Outcome Measure Information:
Title
PASI change from Baseline
Description
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
Title
IGA change from Baseline
Description
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
Title
IGA Responder Rate
Description
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
Title
DLQI change from Baseline
Description
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.
Time Frame
Week 4, 8, and 12
Title
PQOL-12 change from Baseline
Description
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
Title
HADS change from Baseline
Description
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
Title
QVAS change from Baseline
Description
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
Title
Pruritus NRS change from Baseline
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Site 1
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Site 3
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 2
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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