NCT03421613

3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: CDA Research Group, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Treatment of PHN

Interventions

Type	Name	Description
DRUG	3VM1001	Self treatment 3 times daily for 10 days
OTHER	Placebo	Cream without investigational drug. Self treatment 3 times daily for 10 days

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-03-30
• Completion: 2018-05-04
• First posted: 2018-02-05
• Last updated: 2018-07-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study