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

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.

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.

Inclusion Criteria:

• History of type 2 Diabetes mellitus
• Peripheral neuropathy
• Stabilized on pain medication for at least one month
• No previous invasive intervention for pain relief

Exclusion Criteria:

• Local wound or skin abnormality in the applicable area
• Allergic to capsaicin
• Refuse to participate or give consent
• Has other significant disease or receive medication that may worsen neuropathy