Restylane Defyne 1x1ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
Restylane Defyne is the firmest gel in Galderma's OBT™ family: with an elastic modulus of 271 Pa and a deformability of 761 %, it supports deep folds without losing the flexibility that allows facial movement. It is formulated for severe wrinkles and folds — nasolabial fold and marionette lines — where a NASHA gel would be too rigid.
- Cross-linked HA 20 mg/ml
- Lidocaine 3 mg/ml (0.3 %)
- Technology OBT™ / XpresHAn™
- Contents 1 syringe × 1.0 ml
- Needles 2 × 27G ½" UTW
Composition and technology
- Cross-linked hyaluronic acid: 20 mg/ml, of non-animal origin, cross-linked with BDDE and suspended in phosphate buffer solution at pH 7.
- Lidocaine hydrochloride: 3 mg/ml, to reduce discomfort during injection.
- OBT™ technology (Optimal Balance Technology): unlike NASHA gels, which are particulate and minimally cross-linked, OBT modulates the degree of cross-linking to obtain a continuous, soft and deformable gel. Defyne is the variant with the highest degree of cross-linking within OBT.
- Rheological profile: G′ 271 Pa at 0.1 Hz and deformability (xStrain) of 761 %. It is the highest firmness value and the lowest flexibility value of the OBT family: maximum support within a gel that still follows facial expression.
Position within the range: NASHA and OBT
The entire Restylane range is built on two different gel technologies. Choosing between them is the first clinical decision of the treatment.
NASHA® (Non-Animal Stabilized Hyaluronic Acid): firm, particulate gels that retain the long hyaluronic acid chains with minimal cross-linking. High resistance and very low tolerance to deformation: projection, definition and structural support in areas that must hold their shape.
OBT™ (Optimal Balance Technology, called XpresHAn Technology™ in the US market): soft, flexible gels with a variable degree of cross-linking. Low to intermediate resistance and high tolerance to deformation: the gel follows the movement of the tissue, so it is intended for dynamic and expressive areas.
| NASHA — firmness and projection | G′ 416–799 Pa · deformability 7–19 % |
|---|---|
| Restylane / Classyc Lidocaine | HA 20 mg/ml · G′ 701 Pa · 7 % — wrinkles in the mid dermis, lips |
| Restylane Lyft Lidocaine | HA 20 mg/ml · G′ 799 Pa · 17 % — cheekbones, mid third of the face, dorsum of the hands |
| Restylane Eyelight | HA 20 mg/ml — infraorbital hollowing, supraperiosteal plane |
| Restylane Skinboosters Vital / Vital Light | HA 20 and 12 mg/ml — skin quality and hydration, without volumetric purpose |
| OBT / XpresHAn — flexibility and expression | G′ 70–271 Pa · deformability 761–1,442 % |
| Restylane Refyne | HA 20 mg/ml · G′ 70 Pa · 1,442 % — moderate wrinkles and folds |
| Restylane Kysse | HA 20 mg/ml · G′ 160 Pa · 908 % — lips, submucosal plane |
| Restylane Volyme | HA 20 mg/ml · G′ 171 Pa · 930 % — malar volume, supraperiosteal or subcutaneous |
| Restylane Defyne | HA 20 mg/ml · G′ 271 Pa · 761 % — severe wrinkles and folds |
The G′ (0.1 Hz) and deformability (xStrain) values come from peer-reviewed literature (J Drugs Dermatol 2024;23(12):1332–1338). Galderma does not publish official rheological values.
Indications and treatment areas
Injection into the mid to deep dermis for the correction of severe facial wrinkles and folds.
- Nasolabial fold
- Marionette lines
Compared with Restylane Refyne (G′ 70 Pa), indicated for moderate wrinkles, Defyne is reserved for deeper defects that require more structural support.
Technique and treatment protocol
- Injection plane: mid to deep dermis.
- Needles included: 2 units of 27G ½" ultra-thin wall (UTW).
- Technique: linear retrograde threading, serial puncture or a combination of both, with low, constant injection pressure.
- Prior aspiration in accordance with standard clinical protocol to minimise vascular risk.
- Do not combine in the same session with laser treatment, deep peeling or dermabrasion.
- Documented duration: in the pivotal study submitted to the FDA, 77.1 % of subjects maintained an improvement at 6 months and 69.7 % at one year, measured with the WSRS (Wrinkle Severity Rating Scale).
Technical data
| Manufacturer | Q-Med AB (Galderma) — Seminariegatan 21, SE-752 28 Uppsala, Sweden |
|---|---|
| Active substance | Cross-linked hyaluronic acid 20 mg/ml, non-animal origin |
| Anaesthetic | Lidocaine hydrochloride 3 mg/ml |
| Cross-linker | BDDE |
| Technology | OBT™ (XpresHAn Technology™) |
| Vehicle / pH | Phosphate buffer solution, pH 7 |
| Rheology | G′ 271 Pa · deformability 761 % |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needles | 2 × 27G ½" ultra-thin wall |
| Application plane | Mid to deep dermis |
| Sterilisation | Moist heat (syringe contents) / irradiation (needles) |
| Classification | CE-marked medical device (MDR 2017/745) |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: up to 25 °C. Protect from freezing and from sunlight.
- Do not use after the expiry date shown on the pack.
- Single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 1.0 ml, 2 needles 27G ½" UTW, instructions for use and traceability labels for the patient record.
Contraindications and warnings
Contraindications (Galderma instructions for use): known hypersensitivity to streptococcal proteins or to any component of the product; history of severe allergies or of an anaphylactic reaction; hypersensitivity to lidocaine or to amide-type local anaesthetics; porphyria; active skin inflammation or infection in the area to be treated.
Precautions and individual assessment: coagulation disorders or anticoagulant or antiplatelet therapy (increased risk of haematoma and bleeding at the puncture site); history of hypertrophic or keloid scarring; autoimmune disease; presence of permanent implants in the area.
Warnings: do not inject intravascularly or intramuscularly. Intravascular injection can cause embolisation, vascular occlusion, ischaemia, skin necrosis, visual disturbance, blindness or stroke. Aspiration before injecting and low, constant injection pressure are recommended. Do not mix the gel with other products.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the manufacturer's official documentation (Restylane® Defyne™ instructions for use, Q-Med AB / Galderma). This data sheet does not replace the instructions for use accompanying the product.