This proof of concept study is designed to evaluate the safety and efficacy of topically administered Civamide Patch for the treatment of moderate to severe daily pain associated with postherpetic neuralgia localized to the trunk, and with localized post-incisional neuropathic pain syndromes on the trunk.
There will be up to approximately 20 evaluable subjects in this open-label study. The study is composed of a 1-week non-treatment Baseline Period (Day -7 to -1), during which subjects will be required to complete a Daily Diary assessing overall pain and sleep interference. The 1-week Baseline Period will be followed by a 4-week Treatment Period, in which subjects will apply the Civamide Patch (0.015%) daily 12 hours per day, for a period of 4 weeks, complete a Daily Diary assessing overall pain and sleep interference, followed by a 2-week Post-Treatment Observation Period. In the course of the study, subjects will visit the clinic a total of five times for physical examinations, vital signs, review of diaries, and distribution and collection of test patches. Efficacy assessment will be the mean change from Baseline Period in efficacy variables during the course of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
Pain and Rehabilitationi Clinic of Chicago
Chicago, Illinois, United States
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States
U.T. Pain Specialist
Etobicoke, Ontario, Canada
Change in Average Daily Pain Score from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period.
Time frame: Day 29 and Day 43
Average Daily Sleep Score
Time frame: Change from baseline to other weeks in study
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