NCT03511755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

April 3, 2018

Last Update Submit

August 20, 2018

Conditions

PsoriasisStress

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • PASI change from Baseline

    Week 4, 8, and 12

  • IGA change from Baseline

    Week 4, 8, and 12

  • IGA Responder Rate

    Week 4, 8, and 12

  • DLQI change from Baseline

    Week 4, 8, and 12

  • PQOL-12 change from Baseline

    Week 4, 8, and 12

  • +3 more secondary outcomes

Study Arms (2)

TEN 1-11 kHz

EXPERIMENTAL

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

Device: Transdermal Electrical Neuromodulator (TEN)

TEN 1-3 kHz

ACTIVE COMPARATOR

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

Device: Transdermal Electrical Neuromodulator (TEN)

Interventions

Transdermal Electrical Neuromodulator (TEN)DEVICE

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).

Also known as: Thync TEN
TEN 1-11 kHzTEN 1-3 kHz

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site 1

Fremont, California, 94538, United States

Location

Site 3

San Diego, California, 92123, United States

Location

Site 2

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 30, 2018

Study Start

March 12, 2018

Primary Completion

July 24, 2018

Study Completion

July 24, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)