The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy

Corporacion Parc Tauli

Status and phase: Completed; Phase 4

Conditions: Diabetic Complications Neurological; Diabetic Neuropathy; Diabetic Nerve Problems

Treatments: Drug: Capsaicin 8% Patch, Per 10 Square Centimeters; Drug: Lidocaine 5% patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04238208

LIDCAI38920

Details and patient eligibility

About

The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Full description

The aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south Asian male patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Enrollment: 290 patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males aged 40 - 60
• Type 2 diabetes of >10 years duration
• Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)

Exclusion criteria

• Diabetic foot ulcer
• Deformed or contracted foot
• Neurological complications
• Presence of neurological disease
• Presence of cardiovascular or peripheral vascular disease,
• Usage of topical analgesics or implanted medical device six weeks prior to the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 3 patient groups, including a placebo group

Group LL

Active Comparator group

Description:

Group LL patients received the 5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm containing 700 mg of Lidocaine for 60 minutes

Treatment:

Drug: Lidocaine 5% patch

Group LP

Placebo Comparator group

Description:

Group LP received an identical placebo patch

Treatment:

Drug: Lidocaine 5% patch

Group LC

Experimental group

Description:

Group LC received the 8% Capsaicin patch \[8% w/w\] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK).

Treatment:

Drug: Capsaicin 8% Patch, Per 10 Square Centimeters