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What is RESTYLANE?

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A natural beauty lift

Impressions of beauty change with time – as do our faces as we age. With RESTYLANE, you can have a natural beauty lift with the body’s own material. RESTYLANE is a crystal-clear, non-animal, biodegradable gel based on a natural substance, called hyaluronic acid. The gel is injected into the skin in tiny amounts with a very fine needle. The result is instantaneous and produces a long-lasting, natural enhancement, gentle and safe to your skin.

 

Before and after - What results can I expect?

Natural beauty. Made in Sweden

RESTYLANE is made in Sweden, a nation known for health, nature and beauty. Since 1996, more than a million people have been successfully treated in more than 60 countries worldwide.

 

Before and after - other photos of facial contours

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Before After

  

Female, 33 years old
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Before After

  

Female, 42 years old

Indication: Nasolabial folds

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Before After

  

Female, 48 years old

Indication: Nasolabial folds and Glabellar lines

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Before After

  

Female, 51 years old

Indication: Nasolabial and glabellar.

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Before After

  

Female, 54 years old

Indication: Nasolabial folds, Perioral lines, Oral Commissures and Lip line.

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Before After

  

Male, 58 years old

Indication: Glabellar line

Before and after - other photos of wrinkles

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Before After

  

Female, 54 years old

Indication: Nasolabial folds, Perioral lines, Oral Commissures and Lip line.

Before and after - other photos of lips

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RESTYLANE vs. other treatments

How does a treatment with RESTYLANE differ from injections with other products? This comparison chart will answer the question.

  Description Procedure Safety Duration
Botulinum Toxin Type A Botulinum Toxin Type A is a toxin that blocks neuromuscular transmission when injected in tiny amounts into specific muscles to treat and improve lines and wrinkles associated with facial expression.

Manufactured under the names of Botox® and Dysport®

Botulinum toxin is injected in minute quantities. It blocks the nerve impulses to the facial muscles responsible for contraction, thereby relaxing the muscles and smoothing facial lines. It is most effective on frown lines and crow’s feet around the eyes. Accurate dosing and precise positioning are critical in order to freeze the right muscles just enough.

The treatment takes about 30 minutes and the effect of a treatment can be seen within 1 - 2 weeks.

The long-term risks of botulinum toxin are unknown. Redness may occur, as well as bruising, numbness, swelling and headaches. If overdosed or the injection is performed incorrectly, the patient can be left with an immobile face or droopy eyelids until the effect of the injection wears off. The result lasts for about four months.
Collagen treatment Collagen is derived from the hides of cows specially bred for the purpose. Collagen can also be derived from pig skin. Because collagen is an animal product, a collagen test skin implant is administered to determine whether the patient is allergic to the implant, four weeks prior to the treatment.

Collagen is manufactured under many names, two of which are Zyderm and Zyplast.

Collagen can be injected under the skin to fill lines and wrinkles. It is also used for lip enhancement.

The treatment takes less than an hour.

Redness and swelling may occur. Allergic reactions are possible in 3–4% of patients. The effect normally lasts for three to four months.
Stabilized Non-Animal Hyaluronic acid gel (NASHA) Hyaluronic acid is a substance that exists naturally in the body. Its most important function is to carry and bind water. Non-animal, stabilized hyaluronic acid (NASHA) does not contain animal protein and does not require a skin test prior to treatment.

NASHA is a unique form of hyaluronic acid, manufactured under the name of RESTYLANE.

RESTYLANE is designed for different purposes and effects, from reducing wrinkles and folds to enhancing facial contours and sculpting lips. The treatment often takes less than half an hour. Injection-related adverse reactions such as swelling, redness and tenderness might occur. Other adverse reactions are very rare. The result is immediate and can last from 6 - 12 months, depending on the patient and the area that is being treated.

Wrinkle treatment tends to last from 6 - 12 months and lip enhancement for around 6 months.

Other Hyaluronic acid products In addition to RESTYLANE, a range of hyaluronic acid treatments is available. Some of these products are derived from cockscombs bred especially for this purpose.

Hyaluronic acid is manufactured under the names of Hylaform, Juvederm, Rofilan and AcHyal.

Hyaluronic acid is used to treat lips, wrinkles and facial lines. The treatment takes less than an hour to perform. Swelling, redness and tenderness may occur at the site of injection. The duration varies depending on the type of product, the condition of the patient and the area being treated.
Permanent/semi-permanent skin implants Permanent and semi-permanent skin implants contain a range of different synthetic ingredients to make the product last longer.

Permanent and semi-permanent skin implants are manufactured under the names of Artecoll, Dermalive, NewFill, Evolution, Outline and Amazingel.

These products are used to fill lines and wrinkles and to augment lips by injection. Some of the products require at least two treatment sessions. For some of the products, very little or no safety data at all are available. Immediate reactions include redness and swelling at the injection site. Longer-term reactions are also known to occur over time. They include permanent redness, inflammation, lumpiness, skin discoloration or granulomas. The duration differs between the products. Some claim to last for ever, while others offer a sustained improvement for up to twelve months.
Fat injections / liposculpture Fat injections or liposculpture are performed using the patient’s own fat cells (autologous fat) taken from unwanted fat deposits. There are many variables in this treatment, including the way the fat is extracted, whether frozen or fresh fat is used, the area that is injected, the amount of fat that is used and how deeply the fat is injected. The fat is injected under the skin to treat hollow cheeks, to enhance lips or cheeks or to treat deep folds. The procedure is performed under local anaesthesia and can take from less than one hour to several hours. Some lumpiness can occur, in addition to injection-related reactions. If the patient puts on weight, the injected area can become enlarged, which may not be desirable. The reported duration varies from a few months to several years.

Studies and documentation

As a biotechnology company, Q-Med focuses on creating well-being. Research, studies and documentation are therefore crucial for our success. RESTYLANE products have undergone histological and clinical studies in which their safety and efficacy have been tested. A number of comparative studies with other implant materials have also been conducted. The results of some of these studies are presented here.

Significant results in favour of RESTYLANE

In a clinical study in the USA in which RESTYLANE was compared with a collagen-based product, the effect with RESTYLANE was better in six times as many patients as the product with which it was being compared. The study began in 2001 and comprised a total of 138 patients treated at six leading clinics in the USA. Six months after the initial treatment, a follow-up was conducted. The wrinkles that were treated were the so-called nasolabial folds, which run from the bridge of the nose to the corner of the mouth. The patients received treatment with both products, one on each side. The patients and evaluating doctors had no information about which product was being used for each wrinkle.

 

The results of the follow-up revealed that 56.9% of the patients had a better remaining effect from the treatment with RESTYLANE compared with the competing product. The corresponding figure for the competing product was only 9.5%. This means that RESTYLANE produced a better effect in six times as many patients as the competing product. A difference in favour of RESTYLANE was seen at all clinics. The patients’ own assessment of the results also produced better results for RESTYLANE in 52.6%, while the corresponding figure for the collagen product was just 5.8% of all cases. This means that RESTYLANE produced a better effect than the collagen product in nearly ten times as many patients. (Q-MED, 6 May, 2002, Uppsala, Sweden)

The results of the clinical study are the basis of the registration application for RESTYLANE to the FDA (Food and Drug Administration), the American regulatory authority. The application for the registration of RESTYLANE was submitted to the authorities as planned by the middle of 2002. An approval is expected during 2003.

NASHA promising in facial soft-tissue augmentation

In a randomised, patient- and evaluator-blinded study in Canada, 150 patients (140 women and 10 men) seeking treatment for the correction of nasolabial folds (the folds from the root of the nose to the angle of the mouth) were given RESTYLANE Perlane and a competing product (with hyaluronic acid derived from rooster combs) on opposite sides of the face.

 

The study revealed that RESTYLANE Perlane produced a more durable aesthetic improvement than the competing product in 57% of the patients after six months and that fewer treatment sessions were needed to obtain an optimal result with RESTYLANE Perlane than the other product. The results also suggest that RESTYLANE Perlane offers the advantage of lower treatment-related costs and greater satisfaction among patients undergoing the correction of facial folds. (Carruthers, A. New evidence of hyaluronic acid (NASHA) as a dermal filler. Presented at the 11th congress of the EADV, Prague, Czech Republic; 4 Oct 2002)

A combination of RESTYLANE and Botox

A Canadian study suggests that combination treatment with RESTYLANE and Botox is more effective than either product on its own for correcting glabellar lines (lines between the eyebrows). The study comprised 38 women with moderate to severe glabellar lines who were randomised to receive RESTYLANE alone or Botox plus RESTYLANE.

 

The combination of RESTYLANE and Botox proved significantly more effective than RESTYLANE alone over a 28-week follow-up period. The study also revealed that injection-related pain was rated as lower when RESTYLANE was injected after Botox, suggesting that Botox has some analgesic effect. (Carruthers, A. New evidence of hyaluronic acid (NASHA) as a dermal filler. 11th congress of the EADV, Prague, Czech Republic; 4 Oct 2002)

 

 

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