Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Thammasat University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Polyneuropathy

Treatments: Drug: placebo; Drug: Capsaicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00993070

MTU-I-1-45/52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20+ 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 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: Crossover Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Capsaicin

Experimental group

Treatment:

Drug: Capsaicin

placebo

Placebo Comparator group

Treatment:

Drug: placebo