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Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
N/A
Waitlist Available
Research Sponsored by Thync Global, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
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.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BSA x sPGA average percent change from Baseline
Secondary study objectives
BSA change from Baseline
DLQI change from Baseline
HADS change from Baseline
+10 moreOther study objectives
sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active TreatmentActive Control1 Intervention
Active stimulation pulsed current delivered over 15 minutes.
Group II: Control TreatmentPlacebo Group1 Intervention
Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.
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Who is running the clinical trial?
ethica Clinical Research Inc.Industry Sponsor
19 Previous Clinical Trials
1,720 Total Patients Enrolled
Thync Global, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled