NCT03113448

0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Peripheral Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	0.075% Capsaicin Lotion	To apply 3-4 times per day, every day until 8 weeks then stop
DRUG	placebo	To apply 3-4 times per day, every day until 8 weeks then stop

Timeline

• Start date: 2017-01-19
• Primary completion: 2017-04-21
• Completion: 2018-01-31
• First posted: 2017-04-13
• Last updated: 2018-09-12

Locations

1 site across 1 country: Thailand