PsoriasisNCT03511755
12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN
A study testing Transdermal Electrical Neuromodulator (TEN) in people with Psoriasis and Stress, run by Thync Global, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Transdermal Electrical Neuromodulator (TEN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Mar 2018to 24 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 1
Fremont, California, 94538
Site 3
San Diego, California, 92123
Site 2
Santa Monica, California, 90404
About this study
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)
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.
- Being tested
- Transdermal Electrical Neuromodulator (TEN)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Electrical Neuromodulator (TEN)Device
Also called Thync TEN
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).
| Study group | Role | What they receive |
|---|---|---|
| TEN 1-11 kHz | Experimental | Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz) Receives: Device: Transdermal Electrical Neuromodulator (TEN) |
| TEN 1-3 kHz | Active comparator | Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz) Receives: Device: Transdermal Electrical Neuromodulator (TEN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4, 8, and 12
Secondary outcomes (8)
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.
Measured: Week 4, 8, and 12
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.
Measured: Week 4, 8, and 12
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.
Measured: Week 4, 8, and 12
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.
Measured: Week 4, 8, and 12
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.
Measured: Week 4, 8, and 12
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.
Measured: Week 4, 8, and 12
QVAS change from Baseline
Stress Level Quantified Visual Analogue Scale (QVAS) subjective measure of level of stress using an 11-point scale (0-10)
Measured: Week 4, 8, and 12
Pruritus NRS change from Baseline
Pruritus Numerical Rating 11-point Scale (0-10) to assess subjective maximum itch intensity in the previous 24 hours
Measured: Week 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start12 Mar 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thync Global, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511755
- Sponsor's protocol ID
- THY-002
- Status last verified
- Aug 2018
- First submitted
- 3 Apr 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03511755
- Acronym / sponsor ID
- THY-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Thync Global, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEN 1-11 kHz | Experimental | Device: Transdermal Electrical Neuromodulator (TEN)Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz) |
| TEN 1-3 kHz | Active comparator | Device: Transdermal Electrical Neuromodulator (TEN)Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Electrical Neuromodulator (TEN)Also: Thync TENThync 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). | Device | TEN 1-11 kHz, TEN 1-3 kHz |
Primary outcome
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.
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.
8 secondary outcomes
PASI change from Baseline
Time frame: Week 4, 8, and 12
IGA change from Baseline
Time frame: Week 4, 8, and 12
IGA Responder Rate
Time frame: Week 4, 8, and 12
DLQI change from Baseline
Time frame: Week 4, 8, and 12
PQOL-12 change from Baseline
Time frame: Week 4, 8, and 12
HADS change from Baseline
Time frame: Week 4, 8, and 12
QVAS change from Baseline
Time frame: Week 4, 8, and 12
Pruritus NRS change from Baseline
Time frame: Week 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal Electrical Neuromodulator (TEN) in people with Psoriasis and Stress, run by Thync Global, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who reach PASI 50 (50% reduction in PASI score from Baseline) (time frame: Week 4, 8, and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018; AzTrials last refreshed its copy on 30 Oct 2026.