0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

Peripheral Diabetic Neuropathy Clinical Trial

Official title: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial

Status Completed

Clinical Trial Summary

To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial

Clinical Trial Description

Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy.

Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s.

We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively. ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Diabetic Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT03113448
• Study type: Interventional
• Source: Thammasat University
• Status: Completed
• Phase: Phase 3
• Start date: January 19, 2017
• Completion date: January 31, 2018