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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:March 12, 2018
End Date:July 24, 2018

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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.


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.
We found this trial at
3
sites
Fremont, California 94538
Phone: 510-797-0140
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San Diego, California
Phone: 858-571-6800
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Santa Monica, California 90404
Phone: 310-828-8887
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Santa Monica, CA
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