The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with 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. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day. The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
Ramathibodi Hospital
Bangkok, Bangkok, Thailand
Thammasat University Hospital
Pathum Thani, Changwat Pathum Thani, Thailand
Pain relief from pain score reduction, using visual analog scale (VAS)
Time frame: 12 weeks
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