Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Mahidol University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Placebo; Drug: 0.75% capsaicin nanoparticle cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01125215

MUPYPM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matched gel base of capsaicin nanoparticle

Treatment:

Drug: Placebo

Capsaicin

Experimental group

Description:

0.075% capsaicin nanoparticle gel

Treatment:

Drug: 0.75% capsaicin nanoparticle cream