Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125215

Enrollment

Registered

2010-05-18

Start date

2009-09-30

Completion date

2013-12-31

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Diabetic Neuropathy

Keywords

Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing

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.

Interventions

DRUG0.75% capsaicin nanoparticle cream

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026