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.
