Interim Study Results Find Artefill Safe

DANA POINT, CALIF. – The rate of granuloma formation following use of Artefill for the correction of nasolabial folds stands at 0.59%, interim results from a 5-year study have shown.

Dr. Christopher B. Zachary presented 36-month results from the prospective study at the SDEF Summit in Aesthetic Medicine. The study was required by the Food and Drug Administration and is the largest and longest prospective clinical study to date for dermal fillers in the United States and in the European Union, according to Dr. Zachary. 

Dr. Christopher B. Zachary

The purpose of the study is to assess the safety of Artefill (Suneva Medical) in 1,008 patients, based on the incidence of anticipated and unanticipated adverse events and serious adverse events, the incidence of granuloma formation, and subjects' assessment of satisfaction.

Patients were treated for the correction of nasolabial folds at baseline. They received two touch-up treatments if needed, said Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine. The second clinic visit consisted of a clinical evaluation and photos of the treated site 3 months after the last treatment. 

Patients filled out questionnaires at 6, 12, and 18 months and at 2 and 3 years, and will again do so at years 4 and 5. Adverse events were reported to the site for investigation. Final visits are scheduled for 5 years after the last Artefill treatment. 

The mean age of the 1,008 patients was 54 years, 89% were female, and 88% were white. Most subjects (975) are still in the trial, while 29 have been lost to follow-up or withdrew consent for personal reasons, and four non–treatment-related deaths have occurred. 

A total of 114 adverse events deemed device related have occurred to date, for a rate of 11%. These include local complications such as lumpiness, swelling, and redness. In addition, 11 lesions have been identified and biopsied: 4 were viewed as unremarkable at biopsy, 1 was categorized as a foreign body reaction consistent with implant material, and 6 were granulomas, for a rate of 0.59%. Five granulomas resolved completely and one is responding well to treatment. 

"You might say that the 0.59% incidence of granulomas is a bit high when you consider that the worldwide reported incidence of granulomas after using Artefill is 0.04%," said Dr. Zachary. "If the FDA required an intense 5-year study of all the commonly used filler products, where every adverse event [AE] was reported, then you would expect the overall AE incidence to be significantly higher. So what is the real incidence of AEs in fillers, and does reliance on voluntary reporting give us misleading results?" 

Patient satisfaction scores have remained high over time. For example, at 6 months, 81% reported being "very satisfied" or "satisfied" with the cosmetic results, compared with 79% at 18 months, and 78% at 24 months. 

"I'm not up here promoting the product, but I do think Artefill is very safe," Dr. Zachary said. "In practice, this study demonstrates that the product is probably just as safe as hyaluronic acids. Some of my colleagues hate to hear this, and I am not really a fan of permanent fillers, but if we determine that a company needs to perform a comprehensive 5-year safety study, then we need to sit up and take notice of the results. To do otherwise would be ignorant."

Dr. Zachary disclosed that he has received research support, discounts on devices, and honoraria from numerous laser and device companies, including Suneva Medical. He is a member of Suneva’s scientific advisory board.

By: DOUG BRUNK, Skin & Allergy News Digital Network

To see this article in full, please visit Skin and Allergy News at: http://www.skinandallergynews.com/newsletter/the-skinny/singleview40736/interim-study-results-find-artefill-safe/929463f553.html

Skin Tip of the Week: Don't smoke

Don't smoke!!

Smoking makes your skin look older and contributes to wrinkles. Smoking narrows the tiny blood vessels in the outermost layers of skin, which decreases blood flow. This depletes the skin of oxygen and nutrients, such as vitamin A, that are important to skin health. Smoking also damages collagen and elastin — fibers that give your skin its strength and elasticity. In addition, the repetitive facial expressions you make when smoking — such as pursing your lips when inhaling and squinting your eyes to keep out smoke — may contribute to wrinkles.


If you smoke, the best way to protect your skin is to quit. Ask Dr. Skellchock for tips or treatments to help you stop smoking.

If your wrinkles have accelerated due to smoking, consider stopping and then doing a consultation with Dr. Skellchock in her Boca Raton office to see how she can help recapture that youthful appearance.

Recapture Your Youth Event with Dr. Laura Skellchock at Salon Oasis in Boca Raton

Does Radiesse Really Last for One Year?

Radiesse is a new generation cosmetic dermal filler that acts differently than hyaluronic acids, such as Restylane and Juvederm. Several medical studies have shown that Radiesse is a safe and longer lasting treatment.

Radiesse is a new generation cosmetic dermal filler that acts differently than hyaluronic acids, such as Restylane and Juvederm. Several medical studies have shown that Radiesse is a safe and longer lasting treatment that fills and corrects:
- Smile lines
- Nasolabial folds
- Wrinkles around your nose and mouth
- The sunken areas below your eyes (tear trough)

When administered by an experienced cosmetic surgeon, Radiesse can also be an effective treatment for augmenting your cheeks, and filling in the areas on the sides of your chin (your pre-jowl sulcus). Certain physicians who are trained in advanced injection techniques may use Radiesse to help lift sagging areas of the face.

About Radiesse
Radiesse is comprised of calcium-based microspheres that are suspended in a natural gel. This unique composition works with your body, below the surface of your skin, to stimulate the production of collagen and encourage tissue regeneration. Therefore, it does more than just temporarily fill facial lines and wrinkles; it helps your skin rebuild its own foundation.

Longevity of the Treatment
Radiesse has been proven to last up to a year. If you get a touch up every three months or so, this treatment can last about two years. The layering effect is what gives this dermal filler its extra staying power. Results will vary by patient, depending on the technique of your doctor, your metabolism and your amount of movement. Radiesse's superior qualities and longevity make it superior to most other fillers.

Keep in mind, however, that the major disadvantage of Radiesse is also its primary advantage--longevity. If the dermal filler is injected improperly, it can not be reversed. If you are undergoing Radiesse treatment for the first time, it is best to have a small amount injected by a qualified and experienced cosmetic surgeon, not a clinician. The results depend upon the skills and experience of the injector you choose.

Tear Trough Injections
Although Radiesse can be used to treat under-eye hollows (tear troughs), some patients have found the results to be less than desirable. And since Radiesse will last a year, you do not want to deal with irregularities for this duration. Bumps or surface irregularities can become very apparent under the eyes, whether you use cosmetic dermal fillers like Radiesse, hyaluronic acids such as Restylane and Juvederm, autologous fats, or any silicone particle-based solutions.

If You Have an Adverse Reaction
If you have an adverse reaction to Radiesse, you do not live with the outcome for 12 months, there is hope. Wydase can be used to help reverse the effects of hyaluronic-based solutions. Here are some other suggestions if you want to minimize the outcome of your Radiesse injection:
- If you experience visible bumps after your injection, make an immediate appointment with your Boca Raton doctor who can aggressively massage the treated area.
- If discrete white bumps are visible, a tiny incision may be created to "milk" out the material. This will not typically leave a visible scar.
- It is important to address this complication early, as surgical excision becomes extremely difficult months down the road because of your body's reaction to the foreign substance and the potential encapsulation with fibrous scar.

Adverse side effects are very rare. Most cosmetic patients are very happy with the outcome of their Radiesse injections to restore their youthful appearance for 12 months.

To learn more about how Radiesse can help reyou, please visit the website for the Dr. Skellchock's Integrative Dermatology in Boca Raton at www.DrSkellchock.com

Radiesse doctor physician dermatologist for boca raton, delray beach, fort lauderdale, deerfield beach, boynton beach, wellington

Skin Tip of the Week: Protect yourself from the sun

Protect yourself from the sun

The most important way to take care of your skin is to protect it from the sun. A lifetime of sun exposure can cause wrinkles, freckles, age spots and rough, dry skin. Sun exposure can also cause more-serious problems, such as skin cancer. For the most complete sun protection:

• Avoid the sun between 10 a.m. and 4 p.m. This is when the sun's rays are the strongest.
• Wear protective clothing. Cover your skin with tightly woven long-sleeved shirts, long pants and wide-brimmed hats. You might also opt for special sun-protective clothing, which is specifically designed to block ultraviolet rays while keeping you cool and comfortable.
• Use sunscreen when you're in the sun. Apply generous amounts of broad-spectrum sunscreen 30 minutes before going outdoors and reapply every two hours, after heavy sweating or after being in water.

What is a wrinkle, and how are they corrected?

What is a wrinkle?
With time, exposure to the sin and other elements, skin components break down. The skin loses structure and volume. Unwelcome lines and wrinkles appear. Healthcare professionals now can correct wrinkles and facial folds, reversing the signs of aging.

 

How are wrinkles corrected?

The appearance of wrinkles and facial folds can be smoothed by adding structure and volume underneath and bringing sunken skin back up to the surface. Generally, this is done by injecting materials into the skin, to achieve a temporary effect. When administered by a trained healthcare professional, you can be sure that the materials have been proven safe to use. One example is hyaluronic acid.

What is Hyaluronic Acid?

Hyaluronic Acid (HA) is a natural complex sugar found in all living cells, and one of the major components of the dermis connective tissue matrix, along with collagen and elastin.
HA retains water like a sponge, absorbing more than 1000 times its weight. This helps to attract and maintain water, hydrating your skin and increasing its volume and density.
Allergan, Inc., has found ways to produce, purify, and package HA to make it available for wrinkle correction.

What is Juvéderm?

Juvéderm injectable gel is a smooth gel filler you doctor eases under your skin to instantly smooth out those wrinkles or folds that look like parentheses along the sides of your nose and mouth. Results aren't just instant, they're so smooth and natural, everyone will notice but no one will know.

What makes Juvéderm different?

Juvéderm injectable gel is produced through HYLACROSS™ technology results in a smooth consistency gel, which is a primary factor in the long-lasting, smooth, natural look and feel that is a hallmark of Juvéderm wrinkle correction.

What happens during and after Juvéderm treatment?

Dr. Skellchock will assess your facial wrinkles and folds to determine if Juvéderm is right for you.

Wrinkle correction with Juvéderm is a quick, in-office procedure with immediate results.

Common side effects with Juvéderm injectable gel usually are mild.

What is Artefill?

Artefill is a dermal filler.

Finally – a long lasting solution for wrinkle correction!

Artefill:

• is long lasting
• is economical
• feels natural
• requires fewer injections
• is more convenient

If you want an injectable wrinkle filler that provides long lasting wrinkle correction, then ask one of our doctors about Artefill.  If you have used temporary wrinkle fillers in the past, then you know that they are eventually absorbed by your body and require frequent repeat injections to maintain the results you've come to love


Artefill is different from temporary injectable wrinkle fillers. The unique microspheres in Artefill are not absorbed by the body and provide the support your skin needs for natural, long lasting results.

Learn more about the Artefill difference »

Integrative Dermatology is an Artefill Center of Excellence!