Clinical trial NCT03511755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Stress
Lead sponsor: Thync Global, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2018-04-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects who reach PASI 50 (50% reduction in PASI score from Baseline)
timeFrame: Week 4, 8, and 12
measure: Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)
timeFrame: Week 4, 8, and 12
Secondary outcomes:
measure: PASI change from Baseline
timeFrame: Week 4, 8, and 12
measure: IGA change from Baseline
timeFrame: Week 4, 8, and 12
measure: IGA Responder Rate
timeFrame: Week 4, 8, and 12
measure: DLQI change from Baseline
timeFrame: Week 4, 8, and 12
measure: PQOL-12 change from Baseline
timeFrame: Week 4, 8, and 12
measure: HADS change from Baseline
timeFrame: Week 4, 8, and 12
measure: QVAS change from Baseline
timeFrame: Week 4, 8, and 12
measure: Pruritus NRS change from Baseline
timeFrame: Week 4, 8, and 12
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Site 1
state: California
city: San Diego
country: United States
facility: Site 3
state: California
city: Santa Monica
country: United States
facility: Site 2
state: California
Study officials:
References: