Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00993070

Enrollment

Registered

2009-10-09

Start date

2009-10-31

Completion date

2011-12-31

Last updated

2012-05-09

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

Conditions

Diabetic Polyneuropathy

Keywords

capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain

Brief summary

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.

Detailed description

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.

Interventions

DRUGCapsaicin

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

DRUGplacebo

vehicle gel, applied 4 times per day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 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 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)	8 weeks

Secondary

Measure	Time frame
Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)	8 weeks

Countries

Thailand

Outcome results

None listed

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