Factsheet Clodagh Mulcahy Factsheet Clodagh Mulcahy

Restylane

Factsheet on Restylane...

Restylane is one of the newest injectable, non-surgical facial treatments designed to slow and hide the effects of aging. Restylane filler injections are composed of a clear hyaluronic acid-based gel that not only fills in lines and wrinkles in the face, but also adds moisture and lubrication to the skin, making it feel younger and more comfortable. 

What is Restylane?

Restylane  is a clear, non-animal-based, biodegradable gel that is composed of hyaluronic acid, which occurs naturally in the body. Originally developed in Sweden, Restylane filler injections are marketed in the Galderma, a leading pharmaceutical company that offers a wide range of other skin treatments. Restylane is created from tissue cultivated in a laboratory, and is an excellent alternative to other fillers such as collagen and Hylaform, which are both derived from animal products.

Candidates for Restylane Treatment

Restylane® requires only a few injections and no incisions or removal of tissue, so the risk of complications is quite low. That in turn means that almost anyone who would like to reduce the prominence of their facial lines and wrinkles can be a candidate for Restylane treatments. Those allergic to avian-based hyaluronic acid treatments can safely use Restylane, since it is derived from bacterial origins. Those with a history of allergy to bacterial protein, though, should not use the product.

General Restylane Treatment Requirements

Since Restylane treatment requires no incisions and involves a very easy recovery process, it is very rare for a potential patient to be excluded for medical reasons. Furthermore, patients who cannot use other hyaluronic acid treatments because of the bird proteins they contain can receive Restylane injections without risk of allergic reaction. A very small portion of the population may experience an adverse reaction to the bacterial proteins in Restylane®, so patients with a history of such problems should avoid using the product.

As with all cosmetic surgery procedures, it is generally a good idea to wait until after the age of 18 to undergo treatment, since the structure of the face will continue to change throughout adolescence. In addition, qualified patients will have a sound understanding of the possibilities and limitations of the therapy, along with a mature understanding of the risks associated with Restylane. Those who meet these requirements and have facial wrinkles they'd like to see diminished are good candidates for the procedure.

What areas can be treated with Restylane?

Virtually any area of facial skin can be treated with one of the various Restylane dermal fillers. Creases, deep folds, and light wrinkles can all be lessened through the use of Restylane. Laugh lines and fine mouth lines are among the most popular targets for the injections. Enhancement of facial contours, usually accomplished with the larger particle size versions of Restylane, is also possible. Sagging under the eyes, under-projected cheekbones, and recessive chins are often treated with this advanced hyaluronic acid formula. Among other popular applications of Restylane is its use as a lip filler, where it can enhance volume and shape for months after treatment. In short, any area of the face that lacks volume, shape, or smoothness can experience improvement through Restylane injections.

Medical and Health Considerations

Restylane injection is one of the safest cosmetic surgery procedures available, but there are still medical considerations to take into account. As mentioned above, some people may have an allergic reaction to the bacterial protein elements present in the gel; Restylane is not a good option for those susceptible to this problem. There is also very small risk of contracting an animal-born infection from the treatment. Women who are pregnant or breastfeeding should not use Restylane.

Side effects from Restylane treatment are usually minimal. Some redness and swelling may appear, but should be gone within a week. During this time, sunbathing and exposure to cold should be avoided, as these conditions put extra stress on the recovering skin.

Types of Restylane Fillers

There are several types of Restylane fillers, each of which addresses a unique cosmetic concern. Dr. Kelleher will help you decide which type is best suited to your needs and goals.

Restylane

Indications: Moderate facial wrinkles - e.g. frown lines and soft nose to mouth lines.

Restylane is also available with 0.3% lidocaine (a type of anaesthetic) for increased comfort during treatment. 

Restylane Lip Volume

Enhance the volume of your lips with Restylane Lip Volume. Designed specifically to increase volume to enhance or balance the lips, part of the Restylane filler and Skinbooster range for lip treatment. 

Restylane Lip Volume provides improved lip fullness to the body of the lips.  Your Restylane Practitioner will be able to advise you on the appropriate treatment for the aesthetic outcome you are looking for.

Restylane lip, like all other Restylane products are based on stabilised hyaluronic acid of non-animal origin and manufactured using our patented technology called NASHA. This produces a filler gel that many believe is one of the most effective and advanced in the world.

With two decades of research and millions of treatments performed worldwide since 1996, Restylane products have well-documented safety and effectiveness. And perhaps above all - they give results you can truly see and feel, yet always in a natural way. Restylane lip also contains lidocaine to ease discomfort during treatment.   

Indications - Increased lip volume to the body of the lip.

Restylane Lip Volume comes with 0.3% lidocaine (a type of anaesthetic) for increased comfort during treatment. 

Restylane Perlane

Smooth deeper wrinkles and folds such as deep nose to mouth lines or subtly restore lost volume to your facial features. 

A Restylane Perlane treatment provides shaping for facial contours such as minor to moderate contouring of the cheek or eyebrow area, and accentuating the existing features, as well as smoothing out deeper wrinkles and folds.

Indications: - Deep wrinkles and folds, minor to moderate facial contouring, eg, cheek enhancement.

Restylane Perlane is also available with 0.3% lidocaine (a type of anaesthetic) for increased comfort during treatment. 

Restylane Perlane has the largest particle size available. Still in a gel form, Restylane Perlane can correct deep lines, folds, and wrinkles. Restylane Perlane is also the Restylane® filler recommended for use in adding fullness to lips.

Using a pre-measured and sterilized syringe, Dr. Kelleher will gently inject Restylane Perlane into a deeper layer of your skin, followed by a soothing massage to make sure the Restylane® is evenly distributed.

Restylane SubQ

Restylane SubQ - Enhance your facial features by replacing or adding volume to your cheeks or chin. Restylane SubQ is injected deeper than other Restylane products to add or restore lost volume and support to the overall skin structure, providing facial fullness and restoring symmetry.  Youthful cheeks can be restored and facial features better defined. 

Indications: Facial contouring (chin and cheek shaping).

Restylane SubQ is also available with 0.3% lidocaine (a type of anaesthetic) for increased comfort during treatment. 

Restylane SubQ is a NASHA (Non-Animal Stabilized Hyaluronic Acid) based gel that instantly adds volume to the face. It is most often used to contour the cheeks and chin, both of which may have lost volume due to age. Restylane SubQ offers a predictable degree of correction, so it is impossible to over-correct the facial regions that are undergoing treatment. It can quickly and easily create or restore facial symmetry and enhance already prominent facial features.

Injected deep into the skin, Restylane SubQ is ideal for creating or maintaining sharp and stunning cheek bones and profile. Dr. Kelleher will massage the area after injecting Restylane® to distribute it properly, giving you a beautiful face, free of lines and wrinkles.

All Restylane brand fillers contain the same amount of stabilized hyaluronic acid, approximately 20 mg per ml. Because NASHA particles attract water, Restylane results are maintained even as the product begins to break down, making Restylane one of the most cost-effective cosmetic fillers on the market today.

All of the Restylane products come in pre-measured, pre-sterilized glass syringes so it is easy for your Dr. Kelleher to begin treatment.

The Restylane Treatment Process

There are a few precautions to take before your Restylane treatment. It is a good idea to meet with a physician to find out if you are a good candidate for Restylane injections. You should stop taking aspirin and Vitamin E supplements before receiving Restylane, as these can increase bruising or bleeding at the injection site and will also lengthen your healing time. Dr. Kelleher will advise you if any other medications you are taking could interfere with your treatment, and these medications should be avoided as well. If you have any other health concerns, make sure to share these with Dr. Kelleher, as well.

One of the most attractive aspects of the Restylane treatment is that it does not require a preliminary skin test. Because Restylane is a non-animal-based filler and also colorless, there is very little chance that an allergic reaction will occur. This is good news for those who are interested in firming their face, reducing fine lines and wrinkles, and adding volume to lips, but are allergic to the animal components that are found in most other injectibles.

How Does Restylane Work?

The Restylane treatment can take anywhere from a few minutes to a half hour and patients are able to return to work immediately following the procedure.

Prior to administering the injections, Dr. Kelleher may choose to use a local anesthetic to numb the treatment area. Then, a small amount of Restylane filler is injected into the skin with a very thin needle. Because the needle is so thin, there is very little discomfort associated with the injections. The hyaluronic acid molecules that make up the most important part of the Restylane filler naturally draw in water and cause the tissue beneath lines and wrinkles to swell. This immediately fills out wrinkles and gives the skin a smoother surface. The result is a younger looking face in minutes.

Because hyaluronic acid is found naturally in the human body, it will be absorbed back into the body over time, and the effects of Restylane will fade. However, a Restylane treatment lasts longer than other cosmetic fillers, and re-treatment may not be necessary for up to 12 months.

Is Restylane Treatment Painful?

Most patients describe Restylane treatment as being relatively pain-free. The most common complaint is tenderness and redness at the injection site. An extremely thin needle is used to inject the Restylane gel (smaller needles cause less pain than larger needles). A local anesthetic is often used to gently numb the treatment area, especially in the case of lip enhancement. Patients can leave the office immediately after treatment and, although they must be careful to avoid extreme sunlight and heat, they are able to return to normal activity the same day.

Dr. Kelleher may advise you to use an ice pack to reduce side effects such as swelling and tenderness at the injection site. The discomfort associated with treatment should subside within hours or days of the procedure. If it continues past this point, you should notify Dr Kelleher.

Restylane Aftercare

Restylane aftercare is simple and does not generally interfere with the daily routines of patients. Patients should avoid over exposure to heat and sunlight, as they might increase swelling and bruising at the injection site. Also, chemical peels, laser skin resurfacing, laser skin tightening, and other laser enhancements should be avoided as there is a chance that they may cause inflammation. Post-treatment pain should be minimal. A common complaint among those who have undergone Restylane treatment is swelling, though this should subside in the first few days after the injection. Healing time varies from person to person, however, so some may experience redness and swelling slightly longer than others.

Dr. Kelleher will advise their patients to avoid flexing their facial muscles in the area of treatment. Stretching your muscles can disturb the Restylane gel. For the first 24 hours after treatment, it is best to avoid sudden movements in the enhanced area. For example, a patient who has undergone a Restylane treatment for lip augmentation might be advised against excessive laughing, as this will stretch the surrounding muscles and may bother the Restylane gel. As part of the Restylane aftercare procedure, it is also advisable to use a cold pack as needed to reduce swelling and redness at the injection site.

Maintaining Restylane Results

The results of Restylane tend to last longer than other cosmetic fillers. Touchups may be needed after six months in areas that are more prone to movement, such as the lips. Also, some patients desire a touchup treatment during the first two weeks after their initial procedure. However, Restylane injections last, on average, about eight to twelve months. After this time, you may choose to undergo another Restylane treatment, and since each subsequent treatment tends to last longer than the previous one, your results can be easily maintained by seeing Dr. Kelleher regularly. If you don't choose to have additional Restylane injections, the hyaluronic acid will absorb naturally into your skin, and leave no trace of a cosmetic filler.

The most important thing to remember about Restylane treatment and other injectables in its class is that they are temporary and the effects will eventually fade. Although Restylane lasts at least two times longer than other injectables, the most permanent solution to enhancing your face is plastic surgery.

Risks and Benefits of Restylane Injections

The benefits of Restylane® are easy to see: the treatment is fast, minimally painful, and easy to recover from. Furthermore, the results last for months, and the biocompatible nature of the hyaluronic acid in the formula eliminates the need for allergy tests. There is a very small risk of side effects from Restylane® such as contracting an animal-based disease or having an allergic reaction to the bacterial proteins in the gel.

Restylane FAQs

The following represent some of the questions most commonly asked by patients who are interested in rejuvenating their facial skin with Restylane injections.

What is Restylane made of?

Restylane is made of hyaluronic acid, a compound that occurs naturally in the body, where it fills in spaces between other proteins, delivers nutrients, and retains water. Unlike other dermal fillers, Restylane is composed of hyaluronic acid of non-animal origins. Specifically, the biological components of Restylane are created using bacteria in a lab setting, meaning that people with allergies to the bird proteins in other fillers can safely choose Restylane as a facial rejuvenation method.

How does Restylane treatment work?

Restylane treatment works by adding volume to the skin and other facial structures into which it is injected. The hyaluronic acid in the formula is present in the body in nearly identical form already, so Restylane is completely biocompatible with the tissue that it is meant to supplement. The extra volume added by the injections can plump and smooth creased skin or change outward facial contours, depending on how the gel is applied.

Which Restylane product is right for me?

Restylane fillers come in several different forms, all of which contain the same chemical compounds. They differ in terms of the size of their particles, with smaller ones designed to eliminate fine wrinkles and larger ones aimed at softening deeper creases. Dr. Kelleher can discuss your goals with you and help you decide which Restylane alternative is best suited to your needs.

Is testing required prior to Restylane treatment?

Because Restylane is the only alternative not made from animal sources, the allergy testing required for other hyaluronic acid dermal fillers is not necessary prior to Restylane usage. Many patients find this to be one of the great benefits of Restylane, since the testing phase can take weeks to complete.

How long until I see results?

Changes should be apparent almost immediately after Restylane® therapy. Because of swelling and the natural processes involved in the assimilation of the new hyaluronic acid, it will take a few days for your appearance to stabilize. Once this stage has been reached, you should be able to enjoy the benefits of the Restylane® injections for about six months.

What will I look like after Restylane injections?

Immediately following the procedure, patients may notice some swelling and redness, but this will fade within days. The new, rejuvenated look will then appear: the lips or sagging areas of skin will be fuller, large folds will be smoother, and fine lines will be much more difficult to detect. In general, Restylane will give your face a younger, fresher, less tired look than you had before.

What if I am unhappy with my results?

Even good Restylane candidates may sometimes find their results unsatisfactory. If undercorrection is the problem, further injections might offer the patient the best hope of improvement. In the case of overcorrection, though, time is probably the best healer. Since Restylane is gradually absorbed by the body over the months following injection, the extra volume will gradually fade away and the patient will be able to explore options for a more pleasing solution.

What happens if I discontinue Restylane treatment?

Medically, there is no reason why Restylane use cannot be terminated at any time. The procedure is very safe and noninvasive, and each injection application is complete within itself. Please note, though, that while your safety will not be at risk, you may not experience optimal results if you do not follow Dr. Kelleher's suggested treatment program once it has begun.

 

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Botox/Vistabel Factsheet

Fact sheet on Botox/Visabel with links to the Patient Information Sheet

Botox/Vistabel Factsheet

For more detailed information please download the Patient Information Leaflet here http://www.medicines.org.uk/emc/PIL.17544.latest.pdf

Product Summary

[Vistabel - Botulinum Toxin Type A] Currently the number one non-surgical aesthetic treatment in the U.S., Botox® is also the leading brand of botulinum toxin type - A in terms of documented clinical trials and practical use around the world.

Botox®, manufactured by Allergan, was the first botulinum toxin to gain a cosmetic licence endorsing its use for glabellar lines and wrinkles in the US in 2002. It was also eventually licenced for this use in the U.K. in March 2006 under the new brand name of Vistabel® (with a vial dose specific to treat glabellar lines) and was the first brand of botulinum toxin to receive a license for cosmetic use in this country.

Although Botox® is still readily available and used by many UK cosmetic clinics, Vistabel® (although identical in formulation to Botox) is technically the first brand of botulinum toxin type A licensed for cosmetic use in the UK.

 

Generic name of Vistabel®

Clostridium botulinum type - A neurotoxin complex.

 

How is it manufactured?

Vistabel® is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum.

 

How does Vistabel ® work?

It temporarily prevents the release of acetycholine from sympathetic nerve terminals. To learn in detail how Vistabel® injections work, please click on Botulinum Toxin Treatment FAQ.

 

Licenced status

Prescription only medicine

 

Who can perform Vistabel® treatment?

It should be used by trained members of the medical profession only.

 

Licenced UK indications for Vistabel®

In March 2006, Vistabel® was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical `frown` lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient" .

 

Who should not have Vistabel® treatment?

Individuals with a known hypersensitivity to any component of the formulation.

Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).

Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.

Patients who have bleeding disorders of any type.

Pregnant or lactating women.

 

Reported side effects associated with Vistabel® include

Bruising or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.

Click on Botulinum Toxin Side Effects to learn more about the risks or side effects associated with Vistabel®.

 

Costs

Most clinics and practitioners charge by area of the face treated, such as the glabellar lines (frown lines between the eyes).

Practitioners may charge from around £175 - £300 per treatment.

 

Clinical results

Most of the literature on Botulinum Toxin, and hence the clinical evidence and statistics, are based on Botox® as this brand represents around 80% of the world’s use of Botulinum Toxin.

Because it is a prescription only medicine; it had to undergo strict clinical trials in the U.S., where it is approved for cosmetic use, in order to gain a license. Remember, the drug has been licensed in the U.S. since the late 1980s.

Her are the results of a study published in 2001.

500 patients were injected three times in a year with Botox®.They were injected on days 0, 120 and 240.The graph shows that over 70% of the patients showed significant improvement in their glabellar frown lines (i.e. the appearance of their wrinkles when trying not to frown) 30 days after their first injections.This improvement continued after repeat Botox® injections at days 120 and 240.

On the basis of this evidence, most practitioners would now recommend an initial course of Botox® treatment every 3 or 4 months for the first year. It now appears that after this, the time between future injections may lengthen, with practitioners reporting that some patients may only need to return twice a year to maintain results.

Vistabel ® is a registered trademarks of Allergan Inc.

This summary is copyright of http://www.consultingroom.com/treatments/vistabel

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Bocouture/Xeomin Factsheet

Fact Sheet on Xeomin/Bocouture and links to Manufacturer's Patient Information Leaflet

Bocouture/Xeomin

For detail Patient Information Leaflet download this file http://www.medicines.org.uk/emc/PIL.23919.latest.pdf

Product Summary

BOCOUTURE®, botulinum toxin type A, has been available in the U.K. since 2008 as the brand name Xeomin®, which is licenced in the UK for blepharospasm and cervical dystonia.

It gained approval for cosmetic use in the UK in July 2010 and is marketed for this indication, with dosing specific to treat glabellar (frown) lines,  under the brand name Bocouture®.

Bocouture® claims to be an innovative Botulinum type A formulation, in which the complexing proteins have been removed by an extensive purification process from the botulinum toxin complex. In contrast to the other commercially available preparations, Bocouture® contains the pure 150 kD neurotoxin.

It is widely accepted that the bacterial protein present in other products play a role as promoters of an immune reaction, resulting in a loss of effect and reduction in duration of activity. Studies show that Bocouture®, without the complexing proteins, has the lowest content of protein of all of the available botulinum toxins and furthermore show that repeated application of Bocouture®, even in high doses, does not induce the formation of neutralising anti-bodies.

This means that Bocouture® is able to provide similar results to those achievable with the other products without the risk of antibody formation, providing continual long lasting effects. This could be relevant when large doses are being used for medical indications, but many industry experts questions the relevance when this product is used for cosmetic purposes.

 

Generic name of Bocouture®

Clostridium botulinum type - A neurotoxin complex.

 

How is it manufactured?

Bocouture is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum with complexing proteins removed through purification.

 

How does it work?

It temporarily prevents the release of acetycholine from sympathetic nerve terminals.To learn in detail how botulinum toxin injections work, please click on Botulinum Toxin Treatment FAQ .

 

Licenced status

Prescription only medicine

 

Who can perform Bocouture® treatments?

It should be used by trained members of the medical profession only.

 

Licenced UK indications for Bocouture®

In July 2010, Bocouture ® was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical "frown" lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient" . 

 

Who should not have Bocouture® treatment?

Individuals with a known hypersensitivity to any component of the formulation.

Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).

Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.

Patients who have bleeding disorders of any type.

Pregnant or lactating women.

 

Reported side effects include

Bruising or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.

Click on Botulinum Toxin Side Effects  to learn more about the risks or side effects associated with botulinum toxins.

 

Costs

Most clinics and practitioners charge by area of the face treated. These areas are usually defined as crow’s feet, forehead lines, and glabellar lines (frown lines between the eyes).

Practitioners may charge from around £175 - £300 per treatment area.

A discounted rate is usually employed if more than one treatment is required, so that crow’s feet, forehead lines, and glabellar lines may cost £500 or less for the complete package.

BOCOUTURE® is a registered trademark of Merz Pharma.

This summary is copyright of http://www.consultingroom.com/treatments/bocouture

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Dysport/Azzalure Factsheet

Fact Sheet on Dysport/Azzalure and links to Manufacturer's Patient Information Leaflet

Dysport/Azzalure ® Factsheet

For a detailed Patient Information, download the Patient Information Leaflet here http://www.medicines.org.uk/emc/PIL.21990.latest.pdf

 

Product Summary

Azzalure®, botulinum toxin type A, has been available in the U.K. since the early 1990s as the brand name Dysport®, which has licences for various indications in 67 countries worldwide, including the United Kingdom and many European markets.

It gained approval for cosmetic use in the UK in early 2009 and is marketed for this indication, with dosing specific to treat glabellar (frown) lines,  under the brand name Azzalure®.

It is manufactured by the French company Ipsen and commercialised by Galderma.

 

Generic name

Clostridium botulinum toxin (type) A haemagglutinin neurotoxin complex. (125 Speywood units per vial).

 

How is it manufactured?

Azzalure® is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum.

 

How does it work?

It temporarily prevents the release of acetycholine from sympathetic nerve terminals.

 

Licenced status

Prescription only medicine

 

Who can administer the drug?

It should be used by trained members of the medical profession only.  

 

Licenced UK indications

In March 2009, Azzalure® was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical "frown" lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient" . 

The approval was based on several clinical trials involving more than 2,600 patients.

 

Who should not be treated?

Individuals with a known hypersensitivity to any component of the formulation.

Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).

Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.

Patients who have bleeding disorders of any type.

Pregnant or lactating women.

Not recommended by the manufacturer for use in individuals under 18 years of age.

Treatment interval should not be more frequent than every three months as this can increase the risk of antibody formation.

 

Reported side effects associated with cosmetic use include

Bruising, swelling, irritation or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.

 

Clinical data

During the clinical development of Azzalure®, more than 2,600 patients were included in the different clinical trials.

In clinical studies, 1907 patients with moderate to severe glabellar lines have been treated at the recommended dose of 50 Speywood Units. Of these, 305 were treated with 50 units in two pivotal Phase III double-blind placebo-controlled studies and 1200 treated with 50 units in a long-term open-label repeated dose Phase III study. The remaining patients were treated in supportive and dose-ranging studies.

The median time to onset of response was 2 to 3 days following treatment, with the maximum effect observed at day thirty.

In both pivotal placebo-controlled phase III studies, Azzalure® injections significantly reduced the severity of glabellar lines for up to 4 months. The effect was still significant after 5 months in one of the two pivotal studies.

Costs

Most clinics and practitioners charge by area of the face treated. These areas are usually defined as crow’s feet, forehead lines, and glabellar lines (frown lines between the eyes).

Azzalure® is a registered trademark of Galderma.

Information summary copyright of http://www.consultingroom.com/treatments/azzalure

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