CLINICAL TRIALS PROFILE FOR PLIAGLIS

All Clinical Trials for PLIAGLIS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00107835 ↗	Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults	Completed	ZARS Pharma Inc.	Phase 3	2005-05-01	The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00110253 ↗	Duration of Skin Numbing Effect Created by the S-Caine™ Peel	Completed	ZARS Pharma Inc.	Phase 3	2005-06-01	S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of lidocaine and tetracaine. The purpose of this study is to evaluate and measure the length of time the S-Caine Peel numbs the skin, when applied for 30 and 60 minutes.
NCT00110747 ↗	S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Non-Ablative Facial Laser Resurfacing in Adults	Completed	ZARS Pharma Inc.	Phase 3	2005-06-01	Lasers are used for non-ablative resurfacing of facial rhytides, atrophic scars, and a variety of epidermal and dermal lesions. Pain associated with the non-ablative laser treatment has been described as moderate to severe. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate if S-Caine Peel is effective in providing topical local dermal anesthesia for non-ablative facial laser resurfacing in adults.
NCT00110760 ↗	S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Skin Filler Injection in the Face	Completed	ZARS Pharma Inc.	Phase 3	2005-06-01	Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars. There can be substantial pain associated with dermal filler injections. For this reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can be administered by injection or through the use of topical creams and ointments. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate if S-Caine Peel is effective in providing topical local dermal anesthesia for dermal filler injections in adults.
NCT00110773 ↗	S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults	Completed	ZARS Pharma Inc.	Phase 3	2005-06-01	Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.
NCT00125255 ↗	S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children	Completed	ZARS Pharma Inc.	Phase 3	2005-06-01	The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age.

Clinical Trial Conditions for PLIAGLIS

Condition Name

Condition Name for PLIAGLIS
Intervention	Trials
Pain	6
Analgesia	1
Anesthesia of Mucous Membrane	1
Nasolabial Folds	1

Condition MeSH

Condition MeSH for PLIAGLIS
Intervention	Trials
Neuralgia	1
Neuralgia, Postherpetic	1

Clinical Trial Locations for PLIAGLIS

Trials by Country

Trials by Country for PLIAGLIS
Location	Trials
United States	23
China	2

Trials by US State

Trials by US State for PLIAGLIS
Location	Trials
Michigan	4
New York	4
Texas	3
Florida	2
Tennessee	2

Clinical Trial Progress for PLIAGLIS

Clinical Trial Phase

Clinical Trial Phase for PLIAGLIS
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2	1

Clinical Trial Status

Clinical Trial Status for PLIAGLIS
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for PLIAGLIS

Sponsor Name

Sponsor Name for PLIAGLIS
Sponsor	Trials
ZARS Pharma Inc.	7
Galderma Laboratories, L.P.	1
American Association of Endodontists	1

Sponsor Type

Sponsor Type for PLIAGLIS
Sponsor	Trials
Industry	9
Other	2

Clinical Trials Update, Market Analysis, and Projection for Pliaglis

Last updated: October 30, 2025

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Introduction

Pliaglis, a topical analgesic formulation of lidocaine and tetracaine, represents an innovative approach to local anesthesia with applications spanning dermatology and aesthetic procedures. As the pharmaceutical landscape evolves, detailed insights into its clinical trial status, market dynamics, and future projections are imperative for stakeholders. This analysis synthesizes recent updates, evaluates market elements, and forecasts Pliaglis's commercial trajectory.

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Clinical Trials Status and Developments

Regulatory and Clinical Trial Overview

Pliaglis, developed by Galderma, leverages a liposomal gel technology that facilitates targeted delivery of anesthetic agents. It received FDA approval in 2005 for local anesthesia in skin-involving procedures. Since then, its clinical evaluation has transitioned primarily to confirmatory and expanded-use trials rather than initiating new large-scale studies.

Recent clinical activity, as registered on ClinicalTrials.gov, indicates limited ongoing trials primarily focused on:

• Expanded pediatric safety profile: A study assessing efficacy and safety in adolescents aged 12-17, emphasizing safety in younger populations and seeking to extend indications. Its completion status underscores ongoing safety evaluations without imminent new commercial indications.

• Real-world effectiveness studies: Investigations into optimal application protocols and user experience in aesthetic practices, including dermatologic laser procedures.

Key Clinical Findings

• Efficacy: Multiple studies underscore Pliaglis's rapid onset of analgesia (within 15 minutes) and its sustained effect during dermatological procedures lasting up to 20-30 minutes. Its liposomal technology enhances permeation, reportedly reducing the need for systemic analgesics.

• Safety Profile: Adverse events are generally mild, predominantly localized skin reactions such as erythema or transient edema. No serious adverse events linked directly to Pliaglis have been reported in recent trials, underpinning its safety.

Regulatory Landscape

While the FDA approved Pliaglis in 2005, its adoption has grown steadily, especially in dermatological and aesthetic settings. Notably, approvals in other regions, especially Europe, remain limited or proprietary data is awaited, influencing its global market prospects.

Market Analysis

Market Landscape and Competitive Environment

Pliaglis operates within the niche of topical anesthetics used in smooth dermatologic and cosmetic procedures. The broader market, valued at approximately USD 4.2 billion in 2022 with a CAGR of about 6%, is characterized by several competitors:

• Emla (lidocaine/prilocaine): A prominent topical anesthetic with considerable market share due to extensive approval and broad use.
• Ametop (topical tetracaine): Used mainly for intravenous procedures.
• Lidocaine patches and gels: Including brand and generic formulations, targeting localized pain management.

Pliaglis's differentiators include its liposomal delivery system which provides faster onset and potentially better patient comfort, as well as its specific approval for dermatological applications.

Key Market Drivers

• Expansion of aesthetic procedures: The surging popularity of minimally invasive cosmetic treatments boosts demand for topical anesthetics.
• Patient preference for non-invasive options: As patient comfort becomes paramount, topical formulations like Pliaglis gain appeal.
• Regulatory acceptance: Increased global approval would catalyze wider distribution, especially in emerging markets.

Market Challenges

• Pricing and reimbursement: Premium pricing can impede adoption amid cheaper generics.
• Limited indications: Currently restricted mainly to dermatology; expansion into other procedural domains could unlock growth.
• Market penetration: Competition from established generic formulations and alternative anesthetics limits rapid adoption.

Market Projections

Revenue and Adoption Forecast (2023-2030)

Based on current trends:

• Moderate growth scenario: Pliaglis could attain a compound annual growth rate (CAGR) of approximately 8% over the next seven years, driven by expanding aesthetic procedures and increased clinician familiarity.

• Key growth catalysts:

  • Regulatory approvals in Europe and Asia, possibly through strategic partnerships or licensing deals.
  • Indication expansion: Investigating use in pediatric populations or different procedural settings.
  • Product development: Innovations such as dual-function formulations incorporating additional agents.

• Market share assumptions:

  • Pliaglis could capture an additional 10-15% share within the topical anesthetic segment, assuming effective positioning and clinical adoption.
  • Estimated global revenues could reach USD 150-200 million by 2030, up from current estimates of USD 70 million in 2022.

Regional Outlook

• North America: The largest market, benefiting from aesthetic procedure volume and regulatory stability.
• Europe: Opportunities hinge on gaining approval and reimbursement support.
• Asia-Pacific: Growing aesthetic markets and infrastructural development present significant upside, though regulatory pathways could pose challenges.

Strategic Opportunities and Recommendations

• Partnership and Licensing: Collaborating with local players for regional distribution can accelerate expansion.
• Clinical Expansion: Investing in trials for broader indications, including pediatric or pain management applications.
• Product Innovation: Developing formulations targeting specific procedures or combining anesthetic agents for enhanced efficacy.

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Key Takeaways

• Pliaglis maintains a solid safety and efficacy profile, with recent clinical trials reinforcing its role in dermatological procedures.
• Market penetration remains steady but is constrained by competition and limited indications.
• Future growth hinges on regulatory approvals, indication expansion, and strategic partnerships, especially in emerging markets.
• The aesthetic procedural boom presents a robust opportunity, potentially elevating Pliaglis’s revenue to USD 150-200 million by 2030.
• Continuous innovation in formulation and application protocols can sustain its competitive edge.

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FAQs

1. What are the recent clinical advancements for Pliaglis?
Recent trials primarily focus on safety in adolescents and real-world effectiveness in aesthetic procedures. No major new efficacy data have emerged, but ongoing studies reinforce its safety profile.

2. How does Pliaglis compare with other topical anesthetics?
Pliaglis’s liposomal technology offers faster onset and enhanced penetration, providing advantages over traditional lidocaine/prilocaine creams, particularly in dermatological applications.

3. What are the primary barriers to Pliaglis’s market expansion?
Regulatory limitations outside the US, high cost relative to generics, and competition from established topical anesthetics hinder broader adoption.

4. Which regions hold the greatest growth potential for Pliaglis?
Europe and Asia-Pacific represent significant opportunities, contingent on regulatory approvals and market development efforts.

5. How might future clinical trials influence Pliaglis’s market trajectory?
Expanded indications and population safety data could facilitate regulatory approvals in new territories, increasing market share and revenue.

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References

1. ClinicalTrials.gov. "Pliaglis Clinical Trials." [Accessed 2023].
2. Galderma Official Website. "Pliaglis Product Profile."
3. Market Research Future. "Topical Anesthetics Market Analysis." 2022.
4. Transparency Market Research. "Dermatology Drugs Market Outlook." 2022.
5. FDA. "Pliaglis Approval History."

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This comprehensive overview provides the strategic intelligence necessary for stakeholders to assimilate clinical progress, evaluate current market positioning, and identify growth avenues for Pliaglis.