Treatment of PHN Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Tolerability of 3VM1001 Cream for the Treatment of Pain Associated With Post-Herpetic Neuralgia: A Proof of Concept Study
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.
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