Efficacy and Safety Study of Topical Capsaicin in 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy|
- Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
0.025% topical capsaicin applied 4 times per day for 8 weeks
Other Name: Capsika gel
|Placebo Comparator: placebo||
vehicle gel, applied 4 times per day for 8 weeks
Other Name: Placebo
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.
|Thammasat University Hospital|
|Pathumthani, Thailand, 12120|
|Principal Investigator:||Kongkiat Kulkantrakorn, MD||Thammasat University|