Plaque Psoriasis
Conditions
Brief summary
This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0, 2, 8, 12, and 16.
Interventions
DEVICEAutonomic Nerve Modulation - Active
Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
DEVICEAutonomic Nerve Modulation - Control
Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
Sponsors
ethica Clinical Research Inc.
Thync Global, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Outpatient, male or female of any race, 18 years of age or older. This study has no pregnancy restrictions. 2. BSA\* \<10% (excluding palms, soles, intertriginous and inverse areas). 3. sPGA\* ≥3 (NOTE: sPGA score will be averaged across all lesions as opposed to grading target lesions). 4. BSA x sPGA ≥12. 5. Subject diagnosed with chronic plaque psoriasis at least 6 months prior to screening. 6. Treatment-naïve of prohibited biological immunomodulating agents at the time of screening, or decided to stop treatment with the biologic before screening for the study. 7. Be able to follow study instructions and likely to complete all required visits. 8. Sign the IRB-approved ICF (which includes HIPAA).
Exclusion criteria
1. Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic arthritis, or drug-induced psoriasis. 2. Subjects with plaque psoriasis on palms and soles at enrolment. 3. Subjects with plaque psoriasis on the back of the neck that would interfere with device placement. 4. Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis. 5. Other than psoriasis, history of any clinically significant (as determined by Investigator) or other major uncontrolled disease. 6. Psoriasis flare or rebound within 4 weeks of Visit 1 or spontaneously improving or rapidly deteriorating plaque psoriasis during that same time period, as determined by investigator. 7. Use of prohibited medications within the following washout periods: * Biological immunomodulating agents within the prior 12 weeks: etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab pegol (Cimzia), ixekizumab (Taltz) * Biological immunomodulating agents within the prior 24 weeks: ustekinumab (Stelara), secukinumab (Cosentyx), guselkumba (Tremfaya) * Oral drugs within the prior 4 weeks: apremilast, methotrexate, cyclosporine, corticosteroids * Oral drugs within the prior 12 weeks: acitretin * Photochemotherapy (PUVA) within the prior 4 weeks * Phototherapy (UVA/UVB) within the prior 2 weeks * Topical treatment likely to impact signs and symptoms of psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, lactic acid, tar, urea, etc.) within the prior 2 weeks 8. Prolonged sun exposure or use of tanning booths or other source of UV radiation. 9. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for entry into this study. 10. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 11. Exposure to any other investigational drug/device within 30 days prior to study entry. 12. Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BSA x sPGA average percent change from Baseline | Week 16 | Body Surface Area x Static Physician Global Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sPGA change from Baseline | Week 16 | Static Physician Global Assessment |
| BSA change from Baseline | Week 16 | Body Surface Area |
| Mean PASI change from Baseline | Week 16 | Psoriasis Area and Severity Index |
| PASI 50 | Week 16 | Psoriasis Area and Severity Index - 50% reduction |
| PASI 75 | Week 16 | Psoriasis Area and Severity Index - 75% reduction |
| PSSI change from Baseline | Week 16 | Psoriasis Scalp Severity Index |
| DLQI change from Baseline | Week 16 | Dermatology Life Quality Index |
| PQOL-12 change from Baseline | Week 16 | Psoriasis Quality of Life - 12 Item |
| HADS change from Baseline | Week 16 | Hospital Anxiety and Depression Scale |
| Pruritus NRS change from Baseline | Week 16 | Pruritus Numerical Rating Scale |
| Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement) | Week 16 | Pruritus Numerical Rating Scale |
| TSQM | Week 16 | Treatment Satisfaction Questionnaire for Medication |
| QVAS change from Baseline | Week 16 | Stress Level Quantified Visual Analogue Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1) | Week 16 | Static Physician Global Assessment |
Countries
United States
Outcome results
None listed