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

Thync Global

Status

Completed

Conditions

Psoriasis

Stress

Treatments

Device: Transdermal Electrical Neuromodulator (TEN)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03511755

THY-002

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.