Restylane Refyne and Defyne Fillers Approved

Galderma has received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds (NLF) or “laugh lines.”  Restylane® Refyne was approved for the treatment of moderate to severe facial wrinkles and folds and Restylane Defyne for the treatment of moderate to severe, deep facial wrinkles and folds. Refyne and Defyne have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months.1,2

The FDA approval was based on two pivotal, double-blinded, randomized, active-controlled Phase 3 studies investigating Refyne and  Defyne (involving 171 and 162 subjects, respectively) to evaluate their safety and effectiveness. In both studies,  Refyne and Defyne met the studies’ endpoints, with both products showing a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patients. Study investigators used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles, with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles. Investigators reported that 79% of Refyne subjects and 77% of  Defyne subjects had at least a 1-grade improvement on the WSRS after 6 weeks. Subjects also performed self-assessments (SSA) of wrinkle severity, with most subjects reporting at least a 1-grade improvement in SSA scores with Refyne and with Defyne after 6 weeks.

After initial treatment, injection site responses (redness, swelling, bruising, lump/bump formation, pain/tenderness) were predominantly mild or moderate in intensity, temporary (typically with a duration of one to two weeks).

Restylane Refyne and Restylane Defyne were first approved in Europe in 2010 under the brand name Emervel.

The Restylane line of hyaluronic acid fillers is used to help smooth away wrinkles (Restylane & Restylane Lyft), create fuller and more accentuated lips (Restylane Silk), and add lift and volume to the cheeks (Restylane Lyft).

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Bellafill for Acne Scarring

Bellafill for acne scarring is now available at SOMA Skin & Laser in New Jersey

bellafill before and after

Bellafill before and after

What is Bellafill?

Bellafill is an FDA approved dermal filler for the correction of facial wrinkles known as nasolabial folds or smile lines, and the treatment of acne scars. It is a unique, injectable collagen filler with microspheres that can instantly smooth facial wrinkles (nasolabial folds) for beautiful, natural-looking results that last.

How Bellafill Works:
Bellafill replaces lost volume in the skin that are immediate and lasting. The injectable gel is comprised of 80% purified collagen and 20% PMMA (polymethylmethacrylate) microspheres.

Bellafill keeps on working:
Bellafill is different. It restores rather than just fills for natural enduring results. In clinical studies, efficacy was observed out to 12 months. (Primary efficacy endpoint was at 6 months)
Bellafill is an exceptional cosmetic treatment
Bellafill offers a new level of filler rejuvenation. In addition to immediately adding volume to smooth away facial wrinkles known as smile lines, Bellafill helps your skin re-create its own firmer structure for beautiful, younger-looking skin and lasting results.
What to Expect with Bellafill Treatment
Treatment with Bellafill is very similar to treatment with conventional injectable fillers. The main difference is that Bellafill requires a skin test in the United States to identify those patients who may have an allergy to bovine collagen or lidocaine. Lidocaine is provided to minimize discomfort during injection.
First Appointment: Your skin test. A small amount of purified bovine collagen gel is injected in the forearm to ensure you have no adverse reactions to bovine collagen and/or lidocaine.
Second appointment: Four weeks later, if there have been no adverse reactions to the initial test, you are ready for treatment. Upon injection, you will usually see immediate improvement to lines and wrinkles. The amount of Bellafill® required will depend on the severity of the lines/wrinkles being addressed.
Third appointment: A follow-up is suggested at 4-6 weeks. This also allows you to decide if you would like to further enhance or correct the area.
Risks of Bellafill
Bellafill contains lidocaine to lessen the discomfort from the procedure. With proper placement, Bellafill cannot be felt after treatment. You may see immediate results in wrinkle correction and can return to your normal daily activities after the procedure. As with any injectable filler, you may experience temporary pain, swelling and reddening at the treatment site. These side effects are usually gone within a few days. Occasionally, there is transient bruising that typically disappears within 7 days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at injection sites. Two other rare potential side effects of all fillers may be lumps and granulomas, both of which may be treated by your doctor. Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area. Bellafill is FDA approved for the correction of facial wrinkles known as nasolabial folds or smile lines. Patients who have a positive reaction to the Bellafill skin test, a history of severe allergies, known bovine collagen allergies, are allergic to lidocaine, prone to thick scar formation and/or excessive scarring should not receive Bellafill. Mild swelling and redness can occur at the treatment site but generally subside after 24 hours. The safety of Bellafill for use during pregnancy, breastfeeding or in patients under 18 has not been established.  Long-term safety and effectiveness of Bellafill beyond one year has not been established.  For more Safety Information please consult with your physician and the patient labeling that can be found by visiting www.bellafill.com.

Frequently Asked Questions
Q: What is Bellafill?
A: Bellafill is a unique injectable collagen filler with microspheres that support production of the body’s own collagen for beautiful, natural-looking results that last.
Q: What are the microspheres in Bellafill made of?
A: The tiny microspheres in Bellafill are half the diameter of a human hair, so small that they are virtually invisible to the eye. The microspheres are made of polymethylmethacrylate (PMMA), one of the most widely used materials in medicine for 65 years.
Q: How does it work?
A: The collagen in Bellafill provides immediate volume and lift while the microspheres create a matrix that supports collagen production in your skin over time. The microspheres are not absorbed by the body and provide a support matrix for lasting correction.
Q: Is it safe?
A: Yes. The safety profile of Bellafill is comparable to the temporary fillers you are familiar with and perhaps already using.
Q: What are granulomas?
A: Granulomas are inflammatory reactions that may occur with all fillers and can be treated. Bellafill was studied in the longest and largest filler safety study ever conducted. In this long terms safety study, the granuloma rate was 1.7% and majority had resolved or improved with treatment by the end of the study.
Q: Will it work for me?
A: In a clinical trial, Bellafill was shown to work equally well with all skin types, and in men and women. If you have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, or are prone to thick scar formation and/or excessive scarring, tell your provider.
Q: When will I see results?
A: Bellafill replaces lost volume in the skin below the wrinkle for immediate correction and lasting results.
Q: What’s the downtime?
A: You can return to normal activities right away. As with any injectable dermal filler, mild swelling and redness can occur at the treatment site that generally subside after 24 hours.
Q: How long does it last?
A: Bellafill provides a microscopic ‘matrix’ to support your body’s own natural collagen production, and ultimately strengthen the layers of the skin. This provides the support your skin needs for wrinkle correction and younger looking skin, with results that last. In clinical trials, Bellafill showed significant improvement in smile lines at 3 months and 6 months after treatment, and continued to show improvement at 12 months.
Q: Can Bellafill be used in my lips?
A: No.
For full safety information, please refer to the Instructions for Use and patient label copy.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Hand Rejuvenation

After rejuvenating the face, many patients turn their attention to their aging hands. Hands show their age with loss of volume, accentuation of tendons and veins, and the presence of multiple age spots.

Complete hand rejuvenation requires addressing these individual components.

Adding Volume to the Aging Hand

Volumizing fillers can be injected into the backs of the hands. This restores the hand to a more youthful contour and blunts the prominence of tendons and veins. Radiesse can be used for this, as well as some of the hyaluronic acid fillers.

Removing Age Spots from the Aging Hand

Age spots can be quickly removed from the aging hand the same way that they are removed from the face. A RevLite peel, a DEKA resurfacing, or GentleLase spot treatment are all effective in removing age spots.

Sun Protection

Use sunscreen after your procedure to keep your hands looking young.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Juvederm Voluma XC Filler Now Available

JUVÉDERM VOLUMA XC injectable gel is now available in the United States.   This is a hyaluronic acid filler, available for several years in Europe,  intended for deep placement to add volume to the mid-face. JUVÉDERM VOLUMA XC is the first and only filler FDA-approved to instantly add volume to the cheek area. It provides a subtle lift, helping to restore contour and a more youthful profile, for up to 2 years, adding volume to the cheek area.

What else should you know about JUVÉDERM VOLUMA XC?

  • First and only Hyaluronic Acid (HA) filler FDA-approved to instantly add volume to the cheek area, resulting in a subtle lift
  • Clinically proven to last up to 2 years with optimal treatment.
  • After 24 hours, you should be able to resume your normal activities
  • Side effects are moderate and generally last 2 to 4 weeks. Common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.

Hyaluronic Acid (HA) is a naturally occurring, hydrating substance found in your skin. As you age, you start to lose HA, which causes the skin to lose structure and volume.

Before

After - 4.8 mL of JUVÉDERM VOLUMA™ XC was injected into the zygomatic arch, anteromedial cheek, and submalar region

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Botox and Fillers For Men

More men than ever are choosing to get Botox and dermal fillers to preserve and maintain a youthful appearance. There are differences in the treatment of men and women when it comes to cosmetic procedures. For men, it is important to avoid feminizing the face.

Botox for Men

Men often get the forehead and glabella treated, and somewhat less often the crow’s feet area. When injecting men with Botox more units are generally required as compared to women due to the greater muscle mass present in men. Injection to the brow should be kept relatively flat and care should be taken to avoid creating an arched brow, which is usually perceived as feminine.

Men often have heavier brows as compared to women and it important to avoid injections too low on the brow, which can result in forehead ptosis (droop).

Overall, men can benefit from Botox injections by reducing wrinkles on the upper face and periorbital region.

Dermal Fillers For Men

Men can benefit from soft tissue fillers, such as Juvederm or Belotero, to restore volume, especially in the mid-face area and at the nasolabial folds. Men can also benefit from augmentation of the jawline, creating a more masculine firmer jawline. Augmentation of the brow to create a stronger more masculine appearance is also popular.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Sculptra Skin Filler

Sculptra Before and After PhotosSculptra is a skin filler that works differently from the hyaluronic acid fillers (such as Juvederm, Restylane and Belotero). Sculptra is made from poly-L-lactic acid, which helps to replace lost collagen. Sculptra does not work instantly. Rather, it gives you increasing results over time, as it stimulates your body to generate new collagen. The results of a full treatment course of Sculptra, an average of three injection sessions over a few months, can last more than two years. It helps correct shallow to deep facial wrinkles, and folds. Sculptra is suitable for deep folds between the nose and the mouth (nasolabial folds) also called smile lines, the lines framing your mouth (marionette lines), and chin wrinkles.

See more Scultra Before and After Photos

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Juvederm Skin Filler In New Jersey

SOMA Skin & Laser offers Juvederm facial filler injections for rejuvenation and the treatment of wrinkles, as well as other skin fillers Restylane and Belotero. Juvederm is a form of hyaluronic acid, a naturally occurring substance in the body, which can be injected to smooth wrinkles and restore youthful volume. Injection of Juvederm is one of the most popular non-surgical cosmetic procedures in the United States. In the Juvederm procedure, the skin filler material is injected into areas that require volume enhancement. This can be a specific wrinkle or defect, or the entire mid-face to restore the rounded contours of youth. The most commonly treated areas for Juvederm are the wrinkles around the mouth and nose (nasolabial fold), the mid-face (cheeks), and lips, but other areas and defects can be treated as well.

The results of Juvederm are not permanent and must be repeated every few months to maintain the rejuvenating effect. Juvederm XC contain anesthetic making the procedure comfortable and well-tolerated. Juvederm is an excellent first step into the world of cosmetic procedures. Juvederm is also an excellent complement to botox for the treatment of dynamic wrinkles, and rejuvenating laser procedures. At SOMA Skin & Laser, all Juvederm injections are performed by a board-certified dermatologist.

More Juvederm Information

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Belotero Balance Dermal Filler In New Jersey Now Available

SOMA Skin & Laser is now offering Belotero Balance hyaluronic acid filler injections for rejuvenation. Belotero Balance is similar to other fillers, such as Juvederm or Restylane, but is uniquely suited for filling fine lines and wrinkles, such as vertical lip lines and other fine wrinkles. Schedule your free cosmetic consultation by calling us at 973-763-7546.

Learn more about Belotero Balance.

Belotero Balance Before

Belotero Balance Before

Belotero Balance After

Belotero Balance After

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter

Facial Fillers

Dermal fillers, or skin fillers, are materials injected into the skin to reduce the appearance of wrinkles. There are a number of approved dermal fillers on the market, including: Restylane, Juvederm, Radiesse, and Sculptra. The most popular dermal fillers are derived from hyaluronic acid. The discussion below is general and not necessarily relevant to each individual product.

About Dermal Fillers

Dermal fillers are substance injected into or below skin to augment or replace volume. The result are seen immediately, but it may take several visits to achieve the correct correction; some older fillers lose some volume quickly, so “over-correction” is common practice. There is usually no down-time due to the procedure. Most fillers are not permanent, with results lasting about six months. There are many choices, as listed above.

What is hyaluronic acid?

Hyaluronic acid is a naturally occurring glycosaminoglycan found in the dermal matrix of all species without interspecies variability.

What is the ideal skin filler?

No one filler is “ideal” for every application. The general attributes of the ideal filler are:

-Good correction
-Long lasting
-Natural look and feel
-Does Not migrate
-Easy to implant
-Cost effective
-Readily available
-Inert
-Non-carcinogenic
-Non-immunogenic
-Sterile
-Removable

What are the categories of dermal fillers?

-Protein products such as human collagen, bovine collagen, and fascia lata
-polysaccharides such as hyaluronic acid
-fat
-synthetics

How are dermal fillers injected?

There are several possible methods. In the multiple puncture technique, the needle, bevel up, is injected at an angle to the skin of approximately 30 degrees. Multiple injections are made to fill the desired area. In the microdroplet technique, tiny quantities are injected in different planes in the defect. In linear threading, the needle is placed almost parallel to skin and injections made while withdrawing the needle; this may provide too shallow placement for some materials.

For each filler the physician must consider the use, means of injection, proper plane of injection, and desired overcorrection (if any).

Injections can be painful, especially in the central face and perioral areas. Topical anesthesia or ice for 15 minutes prior may be sufficient. Nerve block or regional anesthesia may sometimes be required. Newer fillers include an anesthetic, obviating the need for ice or pre-treatment with a topical agent.

How should the patient be counseled before the dermal filler procedure?

For each dermal filler, the patient should be advised of the risk/benefit ratio (see each specific product for details), and informed of the expected duration of effect. The patient should be instructed to avoid aspirin for 7-10 days prior to the procedure and other NSAIDs for 3 days. The patient should be asked to complete a questionnaire with relevant information, including: medications, history of hypersensitivity reactions, history of herpes facialis, medical history, whether she is pregnant or lactating, any history of autoimmune disease, and importantly what are the patient’s expectations from the procedure and what morbidity is tolerable (e.g. erythema, swelling etc…).

How should the patient be evaluated before the dermal procedure?

The cause of wrinkles and facial damage must be assessed. Are the lines dynamic or static? Is there photodamage, gravitational pull, or aging. Aging results in loss of subcutaneous fat and the prolonged results of the pull of gravity. Photodamage results in breakdown of supporting skin structures, such as collagen and elastin, and can also lead to skin cancer. Evidence of trauma, disease, inflammation, or prior surgery should be sought.

Assessment includes the size, depth, location, and integrity of adjacent structures for each line. Non-facial sites, such as dorsum of the hands, should be inspected as well. All amenable defects should be noted: rhytides, distensible scars (e.g. acne or trraumatic), and the vermillion border of the lip and the oral commisure.

How should the patient be counseled after the dermal filler procedure?

Ice and/or compression can be applied to minimize bruising. It may be helpful to sleep with the head elevated for the first several nights after the procedure in order to minimize edema and ecchymoses. Antiviral medications should be considered for perioral injections in patients with a history herpes labialis.

Generally, who should not receive dermal fillers?

The dermal filler products have not been tested in pregnancy and breast feeding. Dermal fillers should not be injected into an infected or inflamed site. It should not be used in patients with abnormal hemostasis or allergy to any component. Dermal fillers should generally not be used in the glabellar area (see below). Caution should be exercised when using dermal fillers in thin or atrophic skin; the material may be detectable. Each product must be be injected at the specified depth.

Generally, what are the adverse effects of dermal fillers?

The list of possible adverse effects is long. Some are technique-dependent and some due to reactions to the product. Possible adverse effects include: asymmetry; purpura/hematoma; erythema; edema; induration; pruritus; tenderness; dysesthesia; lumps, cysts, abscess; discoloration; intermittent swelling; necrosis; scars; allergy; infection; and extrusion.

Severe adverse effects include: blindness, cerebral infarcts, and fat embolus. These devastating complications can occur with injection into the glabellar and periorbital area, which are supplied by the internal carotid artery. Dermal fillers should be avoided in these areas. Arteriole occlusion manifests as immediate burning and a dusky appearance. If this occurs, the injection must be stopped immediately. Topical nitroglycerine or dimethylsulfoxide (DMSO) may help increase blood flow to area.  Hyaluronidase can be used to dissolve hyaluronic acid fillers. Rarely, connective tissue diseases have been reported to occur with the use of bovine collagen. However, investigatory FDA panels found no evidence of a link.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter