Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Phase 2

• Conditions: Painful Diabetic Neuropathy
• Interventions: Drug: Placebo; Drug: 0.75% capsaicin nanoparticle cream

• Registration Number: NCT01125215
• Lead Sponsor: Mahidol University

Brief 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-05-15
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 any 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched gel base of capsaicin nanoparticle
Capsaicin	0.75% capsaicin nanoparticle cream	0.075% capsaicin nanoparticle gel

Primary Outcome Measures

Name	Time	Method
Pain relief from pain score reduction, using visual analog scale (VAS)	12 weeks

Trial Locations

Locations (2)

Thammasat University Hospital; 🇹🇭 Pathumthani, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand