NCT00993070

Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Detailed description

Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks. Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	Capsaicin	0.025% topical capsaicin applied 4 times per day for 8 weeks
DRUG	placebo	vehicle gel, applied 4 times per day for 8 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-10-09
• Last updated: 2012-05-09

Locations

1 site across 1 country: Thailand