Study to Test Safety and Pain Relief of VMD-3866 Gel Compared to Placebo in Adults With Chemotherapy-Induced Peripheral Neuropathy

What this Trial Is About

Researchers are evaluating VMD-3866 gel, a new non-opioid, non-NSAID topical medicine, for treating pain caused by chemotherapy-induced peripheral neuropathy CIPN. CIPN is nerve damage from certain chemotherapy drugs that causes pain and hypersensitivity. The study aims to see if this gel reduces pain symptoms and to identify any side effects. It works by blocking specific nerve proteins under the skin, reducing nerve activity and pain, with low risk of addiction or interaction with other medicines. This Phase 2a, double-blind, randomized crossover trial involves up to 16 participants who will each receive both the VMD-3866 gel and a placebo gel in two treatment periods separated by a washout of at least 7 days. Before each treatment period, there is a 7-day run-in where participants record pain scores daily. Participants will apply the gel themselves daily, visiting the study site for their first and last doses of each period while self-administering other doses at home. Some participants will have skin biopsies and quantitative sensory testing to assess nerve sensitivity. During the trial, participants will record daily pain scores in a diary and undergo assessments such as pain questionnaires, sleep interference measures, and global impression of change. Safety will be monitored through adverse event reports and skin evaluations. Follow-up calls will occur 7 to 14 days after the last dose or biopsy. The study will measure changes in pain scores and other outcomes to evaluate the gels effect, with total participation lasting up to about one month.

Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)