Ignite Creation Date:
2025-12-18 @ 9:42 AM
Ignite Modification Date:
2025-12-23 @ 10:40 PM
Study NCT ID:
NCT03421613
Status:
None
Last Update Posted:
2018-07-10 00:00:00
First Post:
2018-01-30 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHN
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: