Evolysse™ Smooth
- FDA-approved use
- Moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults 22+
- HA concentration
- 20 mg/mL
- Lidocaine
- 3 mg/mL
- Manufacturer positioning
- Designed for a soft and smooth result
Evolysse™ Filler in Lake Oswego, Oregon
A modern hyaluronic acid injectable for smoothing moderate to severe dynamic facial wrinkles and folds. Evolysse™ Smooth and Evolysse™ Form are FDA-approved for adults age 22 and older, including correction of nasolabial folds — the folds that extend from the sides of the nose toward the corners of the mouth.
At Premier Med Spa of Lake Oswego, injectable care begins with a personalized assessment of your anatomy, goals, medical history, and prior treatment experience. Our physician-led approach is built around an appropriate treatment plan for you, not a one-size-fits-all formula.
Premier Med Spa of Lake Oswego · 8 N State St · Lake Oswego, OR 97034
What is Evolysse™?
Evolysse™ is a collection of prescription injectable hyaluronic acid (HA) gels. In the United States, Evolysse™ Smooth and Evolysse™ Form are FDA-approved for dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults age 22 and older.
Hyaluronic acid is a naturally occurring substance found in skin. In injectable fillers, crosslinked HA is used to add volume and smooth eligible wrinkles and folds. Evolysse Smooth and Form also contain lidocaine to help reduce pain and improve comfort during and after injection.
What is Cold-X™ Technology?
Evolysse is manufactured using Cold-X™ Technology, a near-freezing crosslinking process. Evolus describes Cold-X as being designed to preserve the natural structure of hyaluronic acid and to create products designed to feel natural in the face.
Cold-X is a manufacturing feature, not a guarantee of a particular cosmetic result. Your outcome still depends on appropriate patient selection, anatomy, product choice, amount used, injection technique, and individual response.
What is Evolysse™ FDA-approved to treat?
The current U.S. FDA-approved indication for Evolysse™ Smooth and Evolysse™ Form is dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults age 22 and older.
Nasolabial folds (smile and laugh lines)
Nasolabial folds run from the sides of the nose toward the corners of the mouth. They are often described as smile lines or laugh lines and were the treatment area evaluated in the pivotal U.S. clinical study supporting FDA approval.
Important: Evolus states that the safety and effectiveness of Evolysse products for other treatment areas have not been established. This page therefore does not present lips, cheeks, chin, jawline, tear troughs, temples, marionette lines, or other areas as FDA-approved treatment sites for Evolysse Smooth or Form.
Evolysse™ Smooth vs. Evolysse™ Form
Both products have the same FDA-approved wrinkle-and-fold indication, but they have different formulations and viscoelastic properties. Your provider determines which product is appropriate after evaluating your anatomy and treatment goals.
Evolysse™ Form
- FDA-approved use
- Moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults 22+
- HA concentration
- 22 mg/mL
- Lidocaine
- 3 mg/mL
- Manufacturer positioning
- Designed for lift and support
Clinical evidence and how long results may last
The FDA-reviewed pivotal study included 140 adults with moderate to severe bilateral nasolabial folds. Participants received Evolysse Smooth or Form in one nasolabial fold and Restylane-L in the other, with follow-up through 12 months.
FDA’s Summary of Safety and Effectiveness Data concluded that both Evolysse Smooth and Form were effective for correction of nasolabial folds and that improvements in nasolabial fold severity lasted through one year in the study. A peer-reviewed analysis also reported statistically significantly better blinded-evaluator mean wrinkle-severity improvement versus Restylane-L for Evolysse Form at all visits through 12 months and for Evolysse Smooth at months 6 and 9.
Evolus states that results are immediate and may last a year with optimal correction. Individual results and duration vary, so one year should not be presented as a guarantee.
Results may vary.
What to expect from an Evolysse™ consultation and treatment
Personalized assessment
Your visit begins with a conversation about what you want to change and what you want to preserve. Your provider reviews relevant medical history, medications, allergies, skin concerns, prior filler treatment, and planned procedures before deciding whether Evolysse is appropriate for you.
Treatment and comfort
If you are an appropriate candidate, your provider selects the product, placement, and amount based on your anatomy and treatment plan. Evolysse is injected with a fine needle. Both Smooth and Form contain lidocaine, which is included to reduce pain and improve comfort during and after injection.
Results, settling, and aftercare
Visible correction occurs at the time of injection, although temporary swelling, redness, tenderness, bruising, or other injection-site reactions can affect the early appearance while the area settles.
You will receive aftercare instructions based on your treatment. Evolus advises minimizing exposure to extreme heat or cold while local inflammation is present and discussing the timing of laser treatment, chemical peels, or other procedures with your provider because an inflammatory reaction at the treatment site is possible.
Evolysse™ safety and important information
Evolysse is a prescription medical injectable available only through a licensed physician or properly licensed practitioner. A consultation and medical assessment are required to determine whether treatment is appropriate for you.
Who should not receive Evolysse™?
Do not use Evolysse products if you have a history of multiple severe allergies or severe allergic reactions, including anaphylaxis, or if you are allergic to lidocaine or Gram-positive bacterial proteins.
What should you tell your provider?
Tell your provider if you use aspirin, ibuprofen, blood thinners, or other medications that can prolong bleeding; if you are receiving therapy that decreases your immune response; if you have a history of excessive scarring, pigmentation disorders, or cold sores; or if you are planning laser treatment, a chemical peel, or another procedure.
Tell your provider if you are pregnant or breastfeeding. Safety during pregnancy and breastfeeding has not been studied. Treatment should be postponed in areas with active sores, pimples, rashes, hives, cysts, or infection until healing is complete.
Possible side effects
The most commonly reported side effects with Evolysse products were tenderness, swelling, bruising, redness, lumps, pain, discoloration, itching, and headache. Most were mild and went away on their own within one week. As with all skin injection procedures, infection is also possible.
Rare but serious vascular complications
Unintentional injection into a blood vessel is uncommon, but complications can be serious and may be permanent. Reported risks with facial soft-tissue fillers include vision abnormalities, blindness, stroke, skin injury, and scarring. Changes in vision, signs of a stroke, a white appearance of the skin, or unusual pain during or shortly after treatment require immediate medical attention.
Official safety information: EvolusRx.com — Evolysse Form and Smooth Patient Labeling
Why choose Premier Med Spa of Lake Oswego?
Premier Med Spa of Lake Oswego is a physician-led aesthetic practice at 8 N State St in Lake Oswego. Dr. Jerry Darm serves as Medical Director and is a board-certified physician. Premier’s team page identifies him as a Stanford University graduate with more than two decades of experience in laser and cosmetic medicine.
Our approach to injectables starts with assessment rather than assumption. We consider your anatomy, goals, medical history, and existing treatment plan before recommending a product. If Evolysse is not appropriate for you, the right plan may be a different treatment — or no treatment.
Evolysse™ vs. BOTOX®, Dysport®, and Jeuveau®
Evolysse and neuromodulators are different types of injectable treatment. Evolysse is a hyaluronic acid gel used for its approved facial wrinkle-and-fold indication. BOTOX® Cosmetic, Dysport®, and Jeuveau® are botulinum toxin products that temporarily reduce activity in targeted muscles for their respective approved cosmetic indications.
They are not interchangeable. Some patients may be candidates for one category, both at different treatment sites or times, or neither. Your provider should recommend treatment based on your anatomy, goals, medical history, and the approved labeling for each product.
Evolysse™ FAQ
Is Evolysse™ FDA-approved?
- Yes. Evolysse™ Smooth and Evolysse™ Form received FDA premarket approval for dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults age 22 and older.
What is Cold-X™ Technology?
- Cold-X™ is the near-freezing crosslinking process used to manufacture Evolysse. Evolus states that it is designed to preserve the natural structure of hyaluronic acid and create products designed to feel natural in the face.
What is the difference between Evolysse™ Smooth and Form?
- Both products have the same FDA-approved indication. Smooth contains 20 mg/mL hyaluronic acid and Form contains 22 mg/mL; both contain 3 mg/mL lidocaine. Evolus positions Smooth for a soft and smooth result and Form for lift and support. Your provider selects the formulation based on your treatment plan.
Are Evolysse™ results immediate?
- Visible correction occurs at the time of injection. Temporary swelling, redness, tenderness, bruising, or other injection-site reactions may affect the early appearance while the area settles.
How long does Evolysse™ last?
- In the FDA-reviewed pivotal study, improvements in nasolabial fold severity lasted through one year. Evolus states that results may last a year with optimal correction. Individual results and duration vary.
Does Evolysse™ contain lidocaine?
- Yes. Evolysse Smooth and Form each contain 3 mg/mL lidocaine hydrochloride. The FDA states that lidocaine is included to reduce pain and improve comfort during and after injection. Patients with a lidocaine allergy should not receive these products.
Can Evolysse™ be dissolved?
- Evolus states that because Evolysse is a hyaluronic acid filler, a provider can administer hyaluronidase to dissolve it. Whether hyaluronidase is appropriate, and how it should be used, is a clinical decision for a qualified provider.
Was Evolysse™ studied across different skin types?
- Yes. Evolus states that the clinical study included patient representation from all Fitzpatrick skin types. That is a study-population fact, not a guarantee that every individual is an appropriate candidate.
Is Evolysse™ FDA-approved as a lip or cheek filler?
- The current U.S. FDA-approved indication for Evolysse Smooth and Form is correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults age 22 and older. Evolus states that safety and effectiveness for other treatment areas have not been established.
What are the most common side effects?
- The most commonly reported side effects were tenderness, swelling, bruising, redness, lumps, pain, discoloration, itching, and headache. Most were mild and resolved on their own within one week. Serious vascular complications are uncommon but possible.
How much does Evolysse™ cost at Premier Med Spa?
- For current Evolysse pricing, contact Premier Med Spa or schedule a consultation. Total cost depends on the treatment plan and amount of product recommended for you.
What is the difference between Evolysse™ and Jeuveau®?
- Evolysse is a hyaluronic acid filler. Jeuveau® is a botulinum toxin product used to temporarily improve moderate to severe glabellar frown lines in adults. They work differently and are chosen for different treatment goals.
This page is for general educational information and is not a substitute for individualized medical advice. Indications, contraindications, warnings, precautions, and adverse-event information should be reviewed with your treating provider and against the current manufacturer labeling before treatment.
Personalized Injectable Care in Lake Oswego
Ready to talk about Evolysse™?
Schedule a consultation at Premier Med Spa of Lake Oswego to discuss your goals, review candidacy, and determine whether Evolysse is an appropriate option for you.
Premier Med Spa of Lake Oswego · 8 N State St · Lake Oswego, OR 97034 · Serving Lake Oswego, Portland, and West Linn
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