The study on lidocaine patch 5 percent for acute herpes zoster was designed as a randomized, double-blind, vehicle-controlled, parallel study involving 46 patients with moderate to severe pain caused by acute herpes zoster infection within 4 weeks of onset. Another phase of the study was an open-label, non-randomized, prospective, 2-week trial conducted across 7 clinical trial sites in the United States. Patients applied the lidocaine patch 5% to the area of maximal pain, using no more than 4 patches changed every 24 hours, while maintaining their other analgesic regimens without dose adjustments. The study aimed to investigate the analgesic effect of lidocaine patch 5% on the intense pain associated with acute herpes zoster, as its use had not been previously examined due to potential hazards to damaged skin. The study concluded that lidocaine patch 5%, applied twice a day, is a well-tolerated and effective treatment for moderate to severe pain in acute herpes zoster, likely due to its pharmacological action and physical barrier effect on sensitized skin.
Key Points Explained:
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Study Design:
- Randomized, Double-Blind, Vehicle-Controlled: This design ensures unbiased results by randomly assigning patients to either the treatment group (lidocaine patch 5%) or the control group (vehicle patch), with neither patients nor researchers knowing which group they are in.
- Parallel Study: Both groups were treated simultaneously, allowing for direct comparison of outcomes.
- Open-Label, Non-Randomized Phase: This phase provided real-world data on the patch's effectiveness and tolerability in a less controlled but more practical setting.
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Patient Population:
- Inclusion Criteria: Patients with moderate to severe pain caused by acute herpes zoster infection within 4 weeks of onset were selected. This ensures the study focused on the target population likely to benefit from the treatment.
- Sample Size: 46 patients were included, which, while small, is typical for early-phase studies to assess safety and efficacy.
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Treatment Protocol:
- Application: Patients applied the lidocaine patch 5% to the area of maximal pain, ensuring targeted delivery of the medication.
- Dosage: No more than 4 patches were used, changed every 24 hours, to avoid overuse and potential side effects.
- Concurrent Medications: Patients maintained their other analgesic regimens without dose adjustments, allowing researchers to isolate the effect of the lidocaine patch.
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Study Objectives:
- Analgesic Effect: The primary goal was to investigate the patch's ability to reduce intense pain associated with acute herpes zoster, a condition previously unexamined for this treatment due to concerns about skin damage.
- Safety and Tolerability: The study also assessed how well patients tolerated the patch and any potential side effects.
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Findings:
- Effectiveness: The lidocaine patch 5% was found to be effective in treating moderate to severe pain in acute herpes zoster.
- Tolerability: The patch was well-tolerated, with no significant adverse effects reported.
- Mechanism: The pain relief was attributed to both the pharmacological action of lidocaine and the physical barrier effect on sensitized skin.
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Clinical Implications:
- The study supports the use of lidocaine patch 5% as a viable treatment option for acute herpes zoster pain, offering a non-invasive and well-tolerated alternative to systemic medications.
- The findings highlight the importance of considering both the drug's mechanism and its physical effects when evaluating topical treatments for neuropathic pain.
This structured approach ensures that the study's design, execution, and outcomes are clearly understood, providing valuable insights for healthcare providers and patients considering this treatment option.
Summary Table:
| Aspect | Details |
|---|---|
| Study Design | Randomized, double-blind, vehicle-controlled, parallel + open-label phase. |
| Patient Population | 46 patients with moderate-severe acute herpes zoster pain (≤4 weeks onset). |
| Treatment Protocol | 1–4 patches applied daily to maximal pain area; concurrent analgesics allowed. |
| Key Findings | Effective pain relief, well-tolerated, combines pharmacological + barrier effects. |
| Clinical Implications | Non-invasive alternative for neuropathic pain management. |
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