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Completed

NCT Number: NCT03511755

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1, Fremont, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Thync TEN

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. PASI change 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.

  2. IGA change from Baseline

    Time frame: Week 4, 8, and 12

    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.

  3. IGA Responder Rate

    Time frame: Week 4, 8, and 12

    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.

  4. DLQI change from Baseline

    Time frame: Week 4, 8, and 12

    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.

  5. PQOL-12 change from Baseline

    Time frame: Week 4, 8, and 12

    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.

  6. HADS change from Baseline

    Time frame: Week 4, 8, and 12

    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.

  7. QVAS change from Baseline

    Time frame: Week 4, 8, and 12

    Stress Level Quantified Visual Analogue Scale (QVAS) subjective measure of level of stress using an 11-point scale (0-10)

  8. Pruritus NRS change from Baseline

    Time frame: Week 4, 8, and 12

    Pruritus Numerical Rating 11-point Scale (0-10) to assess subjective maximum itch intensity in the previous 24 hours

Sponsors and collaborators

Lead sponsor

Thync Global, Inc.

Industry

Collaborators

  • ethica Clinical Research Inc.

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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