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Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in the Management of Peripheral Neuropathic Pain ; Early Phase II, Multi-center, Randomized, and Semi-double Blind Controlled Clinical Trial

NCT02228928•Samyang Biopharmaceuticals Corporation

View on ClinicalTrials.gov

Summary

The efficacy and safety of the low concentration \[0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)\] capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•patients who are 18 years of age or older aged having chronic peripheral neuropathy related with a diagnosis of either PHN or DPN
•patients with chronic peripheral neuropathic pain for more than 3 months with an 11-pointed Numeric Rating Scale (NRS) pain score ≥ 4
•patients with DPN and well controlled diabetes were asked to maintain a stable dose of oral hypoglycemic or insulin during the study period
•patients taking concomitant pain medications such as anticonvulsants, antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment
•any conservative therapies such as TENS, physical therapy, chiropractic, massage, biofeedback, or yoga were stopped at least 5 weeks before the enrollment
•women of childbearing age were required to have a negative pregnancy test and were to be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication

Exclusion Criteria

•diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area
•significant pain of an etiology other than PHN or DNP
•other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study
•painful PHN areas located on the face or above the scalp hairline
•an implanted medical device for the treatment of neuropathic pain
•use of topically applied agents including capsaicin-containing products, a 5% lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days
•hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug; and uncontrolled diabetes mellitus or uncontrolled hypertension
•If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2 weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day

Locations (1)

Seoul National University Hospital, Seoula National University Bundang Hospital

Seoul, South Korea

Key Dates

Start Date

February 1, 2009

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

May 1, 2017

Enrollment

ACTUAL participants

Conditions

Peripheral Nerve InjuryPostherpetic Neuralgia

Interventions

CAPNP, 50 ug/cm2 capsaicin patch

DRUG

CAPNP, 100 ug/cm2 capsaicin patch

DRUG

0.075% capsaicin cream

DRUG

Placebo patch

OTHER

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

NCT02359825

Peripheral Nerve Injury

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RECRUITINGNA

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

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Postherpetic NeuralgiaChronic Pain+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Inclusion Criteria

Exclusion Criteria

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

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Predictors of Success After Intercostal Nerve Radiofrequency Treatment for Intercostal Neuralgia