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Product Description

RESTYLANE® 1ml Product Overview

RESTYLANE® 1ml is a non-animal stabilized hyaluronic acid (NASHA™) gel used as a dermal filler for moderate to severe facial wrinkles and folds and for lip augmentation. Developed through bacterial fermentation and stabilized with BDDE, RESTYLANE® is a versatile filler with a concentration of 20 mg/mL. This formulation enables effective and long-lasting results in mid-to-deep dermal layers for facial contouring.

Key Features:

• Hyaluronic Acid Concentration: 20 mg/mL
• Application Areas: Nasolabial folds, perioral wrinkles, and lip augmentation
• Stabilization Process: BDDE cross-linking for enhanced durability

RESTYLANE® 1ml Indications for Use

RESTYLANE® 1ml is indicated for patients seeking correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for submucosal lip augmentation. The product offers mid-to-deep dermal implantation, achieving immediate volumization and wrinkle smoothing.

Primary Indications:

• Moderate to Severe Wrinkle Correction: Effective for nasolabial folds and other deep facial wrinkles.
• Lip Augmentation: Enhances lip fullness and contour in patients over 21 years.

RESTYLANE® 1ml Dosage Information

The dosage of RESTYLANE® 1ml is based on the treatment area and the degree of correction required. Careful injection techniques are essential for optimal results and minimal side effects.

Treatment Protocol:

• Standard Dosage per Area: For nasolabial folds, a maximum of 6 mL per treatment session is advised. For lip augmentation, 1.5 mL per lip per treatment session is the maximum recommended dose.
• Application Depth: Mid-to-deep dermis for wrinkle correction, submucosal layer for lips.
• Injection Technique: A variety of methods are used, such as linear threading and cross-hatching, to ensure even distribution and natural-looking results.

Expected Duration: Results typically last 6-9 months for facial wrinkle correction and up to 6 months for lip augmentation.

RESTYLANE® 1ml Side Effects and Precautions

RESTYLANE® is generally safe with minor side effects, though severe reactions are possible with improper injection technique or allergies.

Common Side Effects:

• Localized Redness and Swelling: Often mild, subsiding within 7 days for nasolabial folds and up to 14 days for lips.
• Bruising and Tenderness: Mild bruising and discomfort may be experienced at injection sites.
• Rare Reactions: Some cases report delayed inflammatory reactions and superficial necrosis if injected improperly.

Precautions:

• Professional Use Only: Should only be administered by trained professionals with dermal filler experience.
• Contraindications: Not for patients with severe allergies (anaphylaxis history), bleeding disorders, or known hypersensitivity to gram-positive bacterial proteins.
• Intravascular Injection Risk: Avoid injection into vascular areas to prevent complications like necrosis and scarring.
• Post-Treatment Guidelines: Patients should avoid excessive sun exposure, UV lamp use, and intense physical activity for 24 hours post-treatment.

RESTYLANE® 1ml Clinical Studies or Real-World Outcomes

Clinical studies on RESTYLANE® show strong efficacy in smoothing wrinkles and enhancing lips, with long-lasting results and high patient satisfaction.

Key Findings:

• Effectiveness in Wrinkle Correction: In a 12-month study, RESTYLANE® significantly improved wrinkle appearance compared to baseline and control.
• Patient Satisfaction: High satisfaction with wrinkle correction, with 93% of nasolabial fold patients reporting an improvement.
• Lip Augmentation Study Results: A randomized study showed that 96% of patients achieved noticeable lip fullness improvement after 8 weeks, with effects lasting for 6 months.

Clinical Observations:

• Longevity of Results: Consistent outcomes for approximately 6-9 months in facial wrinkles, with lip augmentation effects sustained up to 6 months.
• Safety Profile: Few severe adverse events, mostly mild and temporary injection-site reactions.

RESTYLANE® 1ml Composition and Active Ingredients

RESTYLANE® consists of hyaluronic acid stabilized through NASHA™ technology and cross-linked with BDDE, offering durability while maintaining safety.

Key Ingredients:

• Hyaluronic Acid (20 mg/mL): Provides volume and support for facial contours.
• Phosphate Buffered Saline: Maintains pH stability for safe and effective injections.

RESTYLANE® 1ml Drug Interactions

Due to low systemic absorption, RESTYLANE® has limited potential for drug interactions. However, certain medications may still impact the treatment outcome or increase side effects.

Important Considerations:

Concurrent Cosmetic Procedures: If used alongside other dermal treatments, it is advisable to space treatments apart to minimize inflammatory responses.

Anticoagulants: Increased risk of bruising or bleeding; use caution in patients taking blood thinners.

Immunosuppressive Therapy: Patients on immunosuppressants may face delayed healing or higher susceptibility to infection.