Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Thammasat University33 enrolled

Overview

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks. Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Polyneuropathy

Interventions

CapsaicinDRUG

0.025% topical capsaicin applied 4 times per day for 8 weeks

placeboDRUG

vehicle gel, applied 4 times per day for 8 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Thammasat University Hospital

Pathum Thani, Thailand

Outcomes

Primary Outcomes

Pain relief from pain score reduction, using visual analog scale (VAS)

Time frame: 8 weeks

Secondary Outcomes

Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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