Lidocaine Patch for Peripheral Neuropathy

(DLss Trial)

Not currently recruiting at 1 trial location

Overseen By Cathy Revere

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Anti-arrhythmics, Chemotherapy

Disqualifiers: Acute neuropathy, Severe liver disease, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lidocaine patch to determine its effectiveness in reducing pain from peripheral neuropathy, a condition where damaged nerves often cause pain in the feet. Participants will receive either the lidocaine patch or a placebo (a non-active patch) to compare effects. Individuals with ongoing, non-acute nerve pain from conditions like diabetes or past chemotherapy may be suitable candidates. The trial aims to assess whether the lidocaine patch reduces pain more effectively than a placebo. As an unphased trial, this study provides patients the opportunity to contribute to research that could lead to new pain management options.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications related to lidocaine or with anti-arrhythmic properties, like tocainide or mexilitine. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ZTlido 1.8% lidocaine patches are generally safe for use. Studies indicate these patches usually cause only minor side effects, with most users experiencing mild skin reactions at the application site, while serious issues remain rare.

ZTlido has received FDA approval for treating pain from post-herpetic neuralgia, a type of nerve pain that can occur after shingles. This approval confirms its safety for certain conditions. Long-term studies, spanning up to four years, support its safety and effectiveness for pain relief.

Overall, the lidocaine patch is well-tolerated with a low risk of side effects. Existing research and clinical use provide reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for peripheral neuropathy, which often focus on oral medications and nerve pain relief creams, the ZTlido 1.8% lidocaine patch offers a unique, targeted delivery system. This patch allows lidocaine, a local anesthetic, to be absorbed directly through the skin, potentially reducing systemic side effects and offering more localized pain relief. Additionally, the use of diode laser fiber type selective stimulator provides a novel approach by targeting specific nerve fibers, which might offer more precise pain management. Researchers are excited about these treatments because they represent a shift towards more localized and potentially faster-acting solutions for managing the debilitating pain of peripheral neuropathy.

What evidence suggests that the lidocaine patch might be an effective treatment for peripheral neuropathy?

Research shows that the ZTlido 1.8% lidocaine patch, which participants in this trial may receive, could effectively treat nerve pain. Studies have found that applying lidocaine to the skin can reduce pain, especially in conditions like postherpetic neuralgia, which is pain from shingles. With proper use, pain relief can last up to 24 hours. Lidocaine patches have been found to work as well as some oral medications like pregabalin and are generally safe. In one study with patients suffering from postherpetic neuralgia, both lidocaine and another pain relief patch significantly reduced pain. This suggests that the ZTlido patch could be a good option for managing nerve pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with peripheral neuropathy or neuralgia from non-acute causes like diabetes, pre-diabetes, or injury. Participants must be aged 18-70 and not have a medical history of conditions or medications that cause neuropathy. They can't join if they're allergic to lidocaine, currently on chemotherapy, taking certain heart drugs, have acute neuropathy issues like Guillain-Barre Syndrome, severe liver disease, or bleeding problems.

Inclusion Criteria

I do not have foot pain or numbness.

I am 18 or older with long-term nerve pain or pain from plantar fasciitis or an ankle sprain.

I am 18 or older with long-term nerve pain from conditions like diabetes or after chemotherapy, and my pain is significant.

Exclusion Criteria

You have a known allergy to lidocaine or similar types of numbing medication.

I do not have acute peripheral neuropathy like Guillain-Barre Syndrome.

I am not taking medications like lidocaine or those for irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Baseline neuropathic pain evaluation and daily pain severity recording

1 week

1 visit (in-person)

Treatment Period 1

Randomized treatment with either lidocaine or placebo patch

1 week

1 visit (in-person)

Washout

7-day washout period without treatment

1 week

1 visit (in-person)

Treatment Period 2

Daily treatment with the alternate patch not received in the first treatment period

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diode Laser fiber type Selective Stimulator
• ZTlido 1.8 % Topical System

Trial Overview The study tests the effectiveness of a lidocaine patch versus a placebo in reducing pain for those with peripheral neuropathy. It's a double-blind crossover study where participants switch between treatments. Pain levels are tracked daily using visual scales and special equipment measures changes before and after each phase.

How Is the Trial Designed?

Group I: Neuropathy assessment and biomarker testing (Utah) Experimental Treatment 3 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging

Group II: Biomarker Optimization (Stanford) Experimental Treatment 3 Interventions

Screening for neuropathy, foot problems and diabetes Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Quantitative sensory testing ZTlido 1.8% lidocaine patch testing in some subjects

Group III: Crossover testing in participants with painful neuropathy (ZTlido 1.8% lidocaine patch) Active Control 4 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging ZTlido 1.8% lidocaine patch application to both feet for 7 days up to 12 hours per day.

Group IV: Crossover testing in participants with painful neuropathy (placebo patch) Placebo Group 4 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Placebo patch application to both feet for 7 days up to 12 hours per day.

Diode Laser fiber type Selective Stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Lidoderm for:

• Postherpetic neuralgia
• Painful diabetic polyneuropathy

Approved in European Union as Lidocaine for:

• Postherpetic neuralgia
• Other neuropathic pain conditions

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The lidocaine patch has been FDA-approved for treating postherpetic neuralgia and works by blocking sodium channels, which helps reduce pain sensitivity and central nervous system excitability.

Due to its topical application, the lidocaine patch maintains low serum levels even with long-term use, enhancing its safety profile and suggesting potential effectiveness for other chronic neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New analgesics for neuropathic pain: the lidocaine patch. Argoff, CE.[2019]

The 5% lidocaine medicated plaster is effective for treating localized neuropathic pain, particularly in conditions like postherpetic neuralgia and painful diabetic polyneuropathy, showing comparable efficacy to systemic pregabalin.

The lidocaine plaster is generally well tolerated with minimal risk of systemic side effects, making it a safe option for long-term treatment of various neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical pain management with the 5% lidocaine medicated plaster--a review. Mick, G., Correa-Illanes, G.[2019]

In a study involving 18 patients, both the lidocaine and piroxicam patches significantly reduced pain intensity in postherpetic neuralgia, but the lidocaine patch was more effective for allodynia and provided faster pain relief.

The piroxicam patch showed particular effectiveness for dull pain and may be a suitable alternative for patients who cannot use the lidocaine patch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of piroxicam patch compared to lidocaine patch for the treatment of postherpetic neuralgia. Kim, JY., Lim, HJ., Lee, WJ., et al.[2021]

In a study involving 16 patients with non-herpetic focal peripheral neuropathic pain, the lidocaine patch 5% significantly reduced mechanical allodynia and showed a near-significant reduction in persistent pain compared to a placebo.

The lidocaine patch was found to be effective and safe, with only mild skin irritations reported, suggesting it can be a beneficial adjuvant treatment for chronic pain in non-herpetic neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reduction of chronic pain for non-postherpetic peripheral neuropathies after topical treatment with a lidocaine patch]. Meier, T., Faust, M., Hüppe, M., et al.[2018]

In a study of 87 patients with neuropathic and non-neuropathic pain, those with allodynia (sensitivity to touch) experienced significantly greater benefits from topical lidocaine patches, with a tenfold higher likelihood of therapeutic success compared to those without allodynia.

Female patients showed a higher response rate to lidocaine patch treatment (62.5%) compared to males (43.6%), suggesting potential gender-specific effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients]. Kern, KU., Kohl, M., Kiefer, RT.[2021]

In a pilot study involving 16 patients with various refractory peripheral neuropathic pain conditions, 81% reported moderate or better pain relief from using a topical lidocaine patch (Lidoderm) over an average of 6.2 weeks.

The treatment was well-tolerated, with only one patient experiencing mild skin irritation, suggesting that the Lidoderm patch could be a safe option for patients who have not found relief with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. Devers, A., Galer, BS.[2022]

In a study of 31 patients with posttraumatic peripheral neuropathy, the 8% lidocaine pump spray (XPS) significantly reduced pain and tactile allodynia compared to a saline placebo, with effects lasting a median of 5 hours.

XPS was well-tolerated, with only mild local side effects reported, which resolved quickly, highlighting its safety and convenience for managing neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effect of a metered-dose 8% lidocaine pump spray in posttraumatic peripheral neuropathy: a pilot study. Kanai, A., Segawa, Y., Okamoto, T., et al.[2013]

Citations

1. ztlido.com ztlido.com/

ZTlido Efficacy - ZTLido ZTlido is indicated for up to 3 patches a day (12 hours on /12 hours off delivers 24 hours of pain control).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7319520/

A Randomized, Open-Label, Bioequivalence Study of ... Topical lidocaine remains an effective treatment option for PHN over time, with up to 4 years of available safety and efficacy data on long-term ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085434/

The Role of Lidocaine Patches in Combination Therapy: A ... The authors concluded that lidocaine 5% patch is at least as effective as pregabalin for pain relief in PHN with a favorable safety profile and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06030297?intr=ZTLIDO&aggFilters=studyType:int&viewType=Table&rank=5

Diode Laser as a Biomarker for Neuropathic Pain ... Study 2 is designed to see if change in neuropathic pain from treatment with an effective pain reducing agent correlates with change in the biomarker. Lidocaine ...

5. withpower.com withpower.com/trial/phase-neuralgia-10-2022-071ba

Lidocaine Patch for Peripheral Neuropathy (DLss Trial) In a study involving 18 patients, both the lidocaine and piroxicam patches significantly reduced pain intensity in postherpetic neuralgia, but the lidocaine ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/207962Orig1s000SumR.pdf

Summary Review - accessdata.fda.gov ZTlido (lidocaine topical system) 1.8% is a new lidocaine patch developed for the relief of pain associated with post-herpetic neuralgia (PHN).

7. biospace.com biospace.com/press-releases/scilex-holding-company-announces-pain-medicine-news-published-retrospective-claims-data-on-ztlido-vs-lidocaine-5-patch

Scilex Holding Company Announces Pain Medicine News ... More patients treated with ZTlido® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch ...