Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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

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Painful Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Matched gel base of capsaicin nanoparticle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks

Capsaicin

0.075% capsaicin nanoparticle gel

Group Type EXPERIMENTAL

0.75% capsaicin nanoparticle cream

Intervention Type DRUG

0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

Interventions

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0.75% capsaicin nanoparticle cream

0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

Intervention Type DRUG

Placebo

Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No