CLINICAL TRIALS PROFILE FOR PLIAGLIS

All Clinical Trials for PLIAGLIS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

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, Postherpetic	1
Neuralgia	1

Clinical Trial Locations for PLIAGLIS

Trials by Country

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

Trials by US State

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−

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

Pliaglis: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Pliaglis

Pliaglis® is a topical local anesthetic cream, specifically designed for use in various dermatological procedures. It contains a eutectic mixture of 7% lidocaine and 7% tetracaine, which has been proven to provide effective and long-lasting local dermal anesthesia.

Clinical Trials and Efficacy

Numerous clinical trials and studies have demonstrated the efficacy and safety of Pliaglis® in several dermatological procedures. A retrospective, multicenter study involving 35 patients treated with Pliaglis® prior to procedures such as pulsed dye laser, picosecond laser, non-ablative fractional laser, radiofrequency microneedling, and photodynamic therapy, showed promising results[4].

• Pain Reduction: The median and mean pain scores reported by patients were 2 and 2.9, respectively, on a visual analogue scale (VAS) from 0 to 10. More than 65% of the patients had a VAS score of 3 or less, indicating minimal pain during the procedures.
• Effectiveness and Tolerability: Investigators reported the effectiveness of Pliaglis® as “very good” with a median score of 8 and a mean score of 7.5. This was strongly correlated with the pain scores reported by patients.
• Adverse Events: The study found that adverse events were transient and mostly mild, with a mean intensity score of 1.5. This underscores the safety profile of Pliaglis® in clinical practice[4].

Market Analysis

Current Market Presence

Pliaglis® is currently sold in several countries and has been expanding its global reach through strategic licensing agreements. For instance, Crescita Therapeutics has licensed Pliaglis® to commercial partners in 32 countries worldwide, including a recent agreement with STADA for exclusive rights in 15 countries[5].

Launch and Expansion Plans

Croma-Pharma, a global player in the aesthetics market, has announced the launch of Pliaglis® in its European core markets, including Germany, the UK, and Ireland, with further launches planned in Brazil by the end of 2023. This expansion is expected to accelerate Croma-Pharma's growth and strengthen its position in the aesthetics market[2].

Market Growth Drivers

The global market for topical anesthetics, particularly in the context of dermatological procedures, is driven by several factors:

• Increasing Demand for Aesthetic Procedures: The rise in minimally invasive aesthetic treatments has created a higher demand for effective and safe topical anesthetics like Pliaglis®.
• Technological Advancements: Advances in medical technology and the development of new treatments have expanded the scope of procedures where Pliaglis® can be used.
• Globalization and Partnerships: Strategic licensing agreements and partnerships with global pharma players are key to expanding the market reach of Pliaglis®[2][5].

Market Projections

Global Clinical Trials Market

The broader clinical trials market, which includes trials for various drugs and treatments, was valued at USD 80.7 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.49% from 2024 to 2030. This growth is driven by factors such as the rise in chronic diseases, technological evolution, and the globalization of clinical trials[3].

Specific Projections for Pliaglis

Given the positive clinical trial results and the expanding market presence, Pliaglis® is expected to see significant growth:

• Revenue Impact: As launches and sales ramp up, Pliaglis® is anticipated to have a meaningful impact on the recurring revenue of companies like Crescita Therapeutics from 2024 onwards[5].
• Market Penetration: With its proven efficacy and safety, Pliaglis® is likely to become a preferred choice for dermatological procedures, leading to increased market penetration and sales.

Key Takeaways

• Clinical Efficacy: Pliaglis® has demonstrated strong efficacy and safety in reducing pain during various dermatological procedures.
• Market Expansion: The drug is expanding its global reach through strategic licensing agreements and new market launches.
• Growth Drivers: The market for Pliaglis® is driven by increasing demand for aesthetic procedures, technological advancements, and globalization.
• Projections: Pliaglis® is expected to contribute significantly to the revenue of its commercial partners and continue to grow in the market.

FAQs

What is Pliaglis® used for?

Pliaglis® is a topical local anesthetic cream used to provide effective and long-lasting local dermal anesthesia prior to various dermatological procedures such as laser treatments and dermal filler injections.

What are the key ingredients in Pliaglis®?

Pliaglis® contains a eutectic mixture of 7% lidocaine and 7% tetracaine.

What are the common adverse events associated with Pliaglis®?

Adverse events associated with Pliaglis® are typically transient and mild, with a mean intensity score of 1.5. These events are mostly related to the application site and resolve quickly.

Which companies are involved in the commercialization of Pliaglis®?

Companies such as Croma-Pharma, Crescita Therapeutics, and STADA are involved in the commercialization of Pliaglis® through exclusive licensing agreements.

What is the expected market growth for Pliaglis®?

Pliaglis® is expected to see significant growth driven by its expanding market presence, positive clinical trial results, and increasing demand for aesthetic procedures.

Sources

1. Croma-Pharma: Launch of topical anaesthetic Pliaglis® in Europe - PR Newswire
2. Croma-Pharma: Launch of topical anaesthetic Pliaglis® in Europe - PR Newswire
3. Clinical Trials Market Size, Share And Growth Report, 2030 - Grand View Research
4. Real‐life experience of a lidocaine/tetracaine self‐occluding topical anesthetic for dermatological procedures - Wiley Online Library
5. Crescita Therapeutics and STADA Enter 15-Country Exclusive Licensing Agreement for Pliaglis® - Business Wire