Post-herpetic neuralgia (PHN) is pain following acute herpes zoster; defined as pain lasting longer than 3 months. Current first line management consists of tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin. There is an unmet medical need for treatments got topical therapies that demonstrate efficacy without serious side effects.
Post-herpetic neuralgia (PHN) is defined as pain following acute herpes zoster (AHZ) lasting \>3 months. PHN develops in about 10% of patients following an episode of AHZ. 95% of adults ate seropositive for varicella zoster virus antibodies, and are, therefore, at risk for AHZ and PHN. Wider use of AHZ vaccine approved in 2006 may reduce the incidence of PHN. Nevertheless, PHN may be severe and frequently interferes with daily activities and with sleep. First line management of PHN pain currently is tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin, and use of a 5% lidocaine patch. second line therapies include opioid analgesia and topical capsaicin: combinations of topical and systemic therapies may be used as well. These therapies have common side effects of dry mouth, constipation, sedation, urinary retention, nausea, somnolence, dizziness, weight gain and peripheral edema. there is an unmet medial need for topical therapies that demonstrate efficacy without the significant side effects o the therapies mentioned above. 3VM cream, a low concentration of copper in a cream vehicle may b such a therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Medex Healthcare Research, Inc.
Chicago, Illinois, United States
Medex Healthcare Reasearch, Inc.
New York, New York, United States
The time averaged mean in a standard 100 mm visual analog scale (VAS).
The time averaged mean of all patient pain scores over each study period; trend over time for each treatment sill be assessed by day of therapy to evaluate any increase or decrease in effect for each study treatment.
Time frame: 25 days total
Adverse Events, serious adverse events, and study discontinuation
Collection of adverse events and the number of subjects discontinuing he study
Time frame: 25 days total
Patient Global Expression of change Scale (PGIC) from baseline (day 0) to the end of each study period.
This measure is a single-item rating by participants of their improvement with treatment on a 7-point sale that ranges from "very much improved" to very much worse" with "no change "the mid-midpoint".
Time frame: 25 days total
Change in Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase.
Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase. Patients will rate their overall satisfaction with study treatment using a 5-point categorical scale.
Time frame: 25 days total
Use of Rescue medication
recording of the use of rescue mediation at each phase of the study.
Time frame: 25 days total
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