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)

Thync Global, Inc.3 sites in 1 country36 target enrollmentMarch 12, 2018

ConditionsPsoriasis Stress

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Thync Global, Inc.
Enrollment: 36
Locations: 3
Primary Endpoint: Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2018

End Date

July 24, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Thync Global, Inc.

Responsible Party

Sponsor

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
•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.

Outcomes

Primary Outcomes

Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)

Time Frame: Week 4, 8, and 12

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 50 (50% reduction in PASI score from Baseline)

Time Frame: Week 4, 8, and 12

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.