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Last Updated: January 22, 2025

CLINICAL TRIALS PROFILE FOR LIDOCAINE; PRILOCAINE


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All Clinical Trials for Lidocaine; Prilocaine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00154167 ↗ Safety and Efficacy Study of NV-101 in Dental Patients Completed Novalar Pharmaceuticals, Inc. Phase 2 2003-02-01 The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT00355277 ↗ Local Anaesthetic Effects of Transcutaneous Amitriptyline Completed University Hospital, Clermont-Ferrand Phase 1 2005-11-01 The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.
NCT00483990 ↗ Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers Completed Plethora Solutions Ltd Phase 1 2007-03-01 The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers
NCT00556478 ↗ Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Completed Shionogi Inc. Phase 2/Phase 3 2007-10-01 The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
NCT00556478 ↗ Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Completed Plethora Solutions Ltd Phase 2/Phase 3 2007-10-01 The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
NCT00808054 ↗ Evaluation of Analgesia With EMLA and Glucose Oral Solution Completed Federal University of Minas Gerais Phase 4 2008-11-01 In this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lidocaine; Prilocaine

Condition Name

Condition Name for Lidocaine; Prilocaine
Intervention Trials
Pain 12
Contraception 4
Premature Ejaculation 4
Anesthesia, Local 3
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Condition MeSH

Condition MeSH for Lidocaine; Prilocaine
Intervention Trials
Premature Ejaculation 4
Hernia, Inguinal 3
Premature Birth 3
Pain, Postoperative 3
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Clinical Trial Locations for Lidocaine; Prilocaine

Trials by Country

Trials by Country for Lidocaine; Prilocaine
Location Trials
United States 33
Egypt 8
France 5
Italy 3
Austria 3
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Trials by US State

Trials by US State for Lidocaine; Prilocaine
Location Trials
North Carolina 4
California 3
Utah 3
New York 2
Illinois 2
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Clinical Trial Progress for Lidocaine; Prilocaine

Clinical Trial Phase

Clinical Trial Phase for Lidocaine; Prilocaine
Clinical Trial Phase Trials
Phase 4 24
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Lidocaine; Prilocaine
Clinical Trial Phase Trials
Completed 40
Unknown status 11
Not yet recruiting 9
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Clinical Trial Sponsors for Lidocaine; Prilocaine

Sponsor Name

Sponsor Name for Lidocaine; Prilocaine
Sponsor Trials
Plethora Solutions Ltd 5
Assiut University 4
Cairo University 4
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Sponsor Type

Sponsor Type for Lidocaine; Prilocaine
Sponsor Trials
Other 78
Industry 12
NIH 2
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Lidocaine and Prilocaine: Clinical Trials, Market Analysis, and Projections

Introduction

Lidocaine and prilocaine, commonly combined in the topical anesthetic cream known as EMLA (Eutectic Mixture of Local Anesthetics), have been widely used for various medical and cosmetic procedures. This article will delve into recent clinical trials, market analysis, and future projections for these anesthetic agents.

Clinical Trials and Efficacy

Pain Management During Vaccinations

A recent randomized controlled trial highlighted the efficacy of topical lidocaine-prilocaine (EMLA®) in managing infant pain during pneumococcal vaccinations. The study showed that applying EMLA cream before vaccination significantly reduced infants' pain expression, measured by the FLACC (Faces, Legs, Activity, Cry, Consolability) score, and increased the latency to cry. This indicates that EMLA cream is an effective tool for pain management in pediatric settings[1].

Dermal Analgesia

Clinical studies have consistently demonstrated the effectiveness of EMLA cream in providing dermal analgesia. For instance, applications of EMLA cream for at least one hour before procedures such as IV cannulation or venipuncture have shown significant analgesic effects compared to placebo or ethyl chloride. EMLA cream has been found to be comparable to subcutaneous lidocaine but less efficacious than intradermal lidocaine[4].

Market Analysis

Current Market Size and Growth

The lidocaine and prilocaine cream market is experiencing steady growth, driven by increasing demand for topical anesthetics across various medical fields. The market is anticipated to witness a compound annual growth rate (CAGR) of 7.99% from 2024 to 2031, growing from a valuation of USD 6.6 billion in 2024 to USD 11.3 billion by 2031[2].

Key Drivers

Several factors are driving the growth of the lidocaine and prilocaine cream market:

  • Growing Demand for Minimally Invasive Procedures: The rise in cosmetic surgeries, laser treatments, and minor invasive procedures has increased the use of topical anesthetics like lidocaine and prilocaine[2].
  • Increasing Prevalence of Skin Conditions: The growing prevalence of dermatological conditions and the need for local pain management are fueling market demand[2].
  • Advancements in Formulations: Innovations in pharmaceutical formulations, such as liposomal lidocaine, which provide sustained release and prolonged pain relief, are enhancing treatment outcomes and driving market growth[3].

Regional Market Dynamics

The global lidocaine and prilocaine cream market is diverse, with different regions contributing to its growth:

  • North America: Dominates the market due to high research and development activities and an increase in surgical procedures, particularly in dentistry and dermatology[3].
  • Europe: Characterized by a mature market with well-established infrastructure and consumer preferences[2].
  • Asia-Pacific: Rapidly growing due to a large population, rising disposable income, and increasing urbanization[2].
  • Latin America and Middle East & Africa: Present opportunities and challenges, with economic fluctuations and urbanization driving demand in these regions[2].

Market Projections

Future Growth Prospects

The lidocaine and prilocaine cream market is poised for significant growth:

  • CAGR of 7.99%: Expected from 2024 to 2031, indicating a robust expansion in the market[2].
  • Increasing Urbanization: The rising urban population, especially in urban centers, is propelling the demand for lidocaine and prilocaine cream[2].
  • Sustainable Solutions: Growing environmental concerns and stringent regulations are fostering a shift towards sustainable and eco-friendly lidocaine and prilocaine cream products[2].

Innovations and Advancements

The market is driven by ongoing innovations:

  • Advanced Delivery Systems: Developments such as liposomal formulations of lidocaine are designed to provide sustained release and prolonged pain relief, enhancing treatment outcomes[3].
  • Mergers and Acquisitions: Companies are consolidating their market positions through mergers and acquisitions, expanding their product portfolios, and leveraging synergies to drive growth[2].

Key Players

The lidocaine and prilocaine cream market includes several key players:

  • Tongfang Pharma
  • Aspen Pharma
  • Octavius Pharma
  • Padagis
  • Akorn

These companies are actively involved in research and development, expanding their product offerings, and enhancing their market positions through strategic consolidations[2].

Pharmacokinetics and Safety

Plasma Concentrations and Elimination Half-Life

Studies have shown that neonates have comparable plasma lidocaine and prilocaine concentrations to those found in older pediatric populations. The elimination half-life of lidocaine is approximately 65 to 150 minutes, while that of prilocaine is around 10 to 150 minutes. These pharmacokinetic parameters are crucial for safe and effective use, especially in special populations such as the elderly and those with hepatic or renal dysfunction[4].

Contraindications and Warnings

EMLA cream is contraindicated in patients with a known history of hypersensitivity to lidocaine or prilocaine. It is also not recommended in clinical situations where penetration or migration beyond the tympanic membrane into the middle ear is possible due to ototoxic effects observed in animal studies[4].

Conclusion

Lidocaine and prilocaine, particularly in the form of EMLA cream, are essential components in modern pain management. With their proven efficacy in clinical trials and the growing demand driven by various medical and cosmetic procedures, the market for these anesthetic agents is set for significant expansion. Innovations in formulations, increasing urbanization, and the need for sustainable solutions are key factors driving this growth.

Key Takeaways

  • Efficacy in Pain Management: EMLA cream is effective in reducing pain during procedures like vaccinations and minor surgeries.
  • Market Growth: The lidocaine and prilocaine cream market is expected to grow at a CAGR of 7.99% from 2024 to 2031.
  • Innovations: Advanced delivery systems and sustainable solutions are driving market growth.
  • Regional Dynamics: North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa are key regions contributing to market growth.
  • Pharmacokinetics and Safety: Understanding the pharmacokinetic parameters and contraindications is crucial for safe use.

FAQs

  1. What is the expected growth rate of the lidocaine and prilocaine cream market?

    • The market is anticipated to witness a compound annual growth rate (CAGR) of 7.99% from 2024 to 2031[2].
  2. What are the key drivers of the lidocaine and prilocaine cream market?

    • Growing demand for minimally invasive procedures, increasing prevalence of skin conditions, and advancements in formulations are key drivers[2].
  3. Which regions are significant in the global lidocaine and prilocaine cream market?

    • North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa are significant regions[2].
  4. What are the contraindications for EMLA cream?

    • EMLA cream is contraindicated in patients with a known history of hypersensitivity to lidocaine or prilocaine and in situations where penetration beyond the tympanic membrane is possible[4].
  5. What innovations are driving the market growth for lidocaine and prilocaine?

    • Advanced delivery systems such as liposomal formulations and the development of sustainable and eco-friendly products are driving market growth[2][3].

Sources

  1. Olsson Duse, B., Sporrong, Y., Bartocci, M., & Skoglund, K. (2021). Efficacy of topical lidocaine‐prilocaine (EMLA®) for management of infant pain during pneumococcal vaccination: A randomized controlled trial. Pain Practice, 10.1002/pne2.12070.
  2. OpenPR. (2024). Lidocaine and Prilocaine Cream Market Size, Share and Forecast.
  3. Data Bridge Market Research. (n.d.). Lidocaine Market Size, Share, Trends, & Report Analysis By 2031.
  4. FDA. (2018). EMLA CREAM (lidocaine 2.5% and prilocaine 2.5%) - Label. Accessdata.fda.gov.

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