NCT01125215

Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	0.75% capsaicin nanoparticle cream	0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
DRUG	Placebo	Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2010-05-18
• Last updated: 2013-04-11

Locations

2 sites across 1 country: Thailand