The US Food and Drug Administration (FDA) has approved the injectable dermal filler Radiesse (Merz North America, Inc) for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4.
Earlier this year, as reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risks. A majority of panelists also voted that it is safe and effective.
“Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year,” the company said.
Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation — and is approved in 52 countries for that indication.
Data to support FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks.
The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) — validated by the company in another study — and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results.
According to the MHGS, 75% of Radiesse patients experienced at least a one-point improvement at 3 months compared with 3% of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.
In addition, 98% of treated patients reported improvement in the appearance of their hands at 3 months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the company said.
Most adverse events were injection site reactions such as swelling, redness, pain, and bruising, which were usually mild to moderate, short in duration (lasting about 1 week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company.
Radiesse is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
Microdermabrasion is one of the most recent techniques that has crossed over into the mainstream of skin care. Microdermabrasion employs a high pressure handheld device that circulates exfoliating micro crystals onto the skin and then uses suction to remove the outer skin layer that consists of dead skin cells.
Microdermabrasion can reduce enlarged pores, help in the removal of fine scars, lines and wrinkles and improve the appearance of acne, blotchy skin, sun damage or uneven texture. Microdermabrasion is an excellent, safe, and effective procedure that produces great results with no “downtime”. And, in conjunction with a chemical peel or laser genesis, it is the gold standard in premium skincare for all skin types.
Call Dolce Aesthetics NY at 718-365-2369 and one of our skin care specialists will be happy to answer any questions you may have. Our office is conveniently located only a few blocks off Woodhaven Boulevard and adjacent to the Jackie Robinson Parkway at 87-47 Myrtle Avenue in Glendale.
SKIN MEDICA PEELS
Illuminize Peel, Vitalize Peel, Rejuvenize Peel
Illuminize Peels are for mild skin imperfections this non-invasive very superficial chemical peel utilizes a new approach to chemical peeling. This peel is known as the red carpet peel. It can be done the day of or the day before an important event that you want your skin to look refreshed and youthful. This peel gives you an amazing glow and tightens skin. Restores more youthful appearance Improves clarity, color, skin texture, minimizes pores, some fine lines, and also helps with minimal acne breakouts.
Vitalize Peels are for mild to moderate skin imperfections. Vitalize Peels helps fight the effects of time, sun damage and environment damage. It will reduce fine lines, wrinkles and scarring. It also tightens and firms skin. Improves the texture of your skin. Vitalize Peels will reduce skin imperfections.
Rejuvenize Peels are for moderate to severe skin imperfections it is an advanced formulation of peeling agents, with a built-in anti-irritant and penetration enhancer that provides controlled exfoliation of the uppermost damaged layers of the skin to reveal a fresher and healthier looking skin. Provides maximum results with minimal down time. Rejuvenize peel will reduce skin imperfections, such as sun damage, fine lines, wrinkles and acne scarring .Rejuvenize peel will reduce signs of aging, you will have a healthier more radiant youthful appearance. It will brighten the skin and improve color and clarity. You will see noticeable improvements with just one peel.
A Healthier, Younger-looking skin can be yours, with these non-invasive peels.
Many individuals who are getting started often wonder, ”What is laser hair removal?” Laser hair removal is an aesthetic procedure that is done with the use of a laser light. As long as patients take the proper precautions and get treated only by a certified, experienced laser technician, the treatment will be safe and effective.
One of the most important factors of laser hair removal is the person performing your treatment. The next important factor is the equipment being used. Laser technologies have been developed to treat all skin types, making treatments more effective for patients.
When the laser equipment is not right for your skin type, there could be potential danger. Here at Dolce Aesthetics NY, we use a Alexandrite 755 for light skin and a YAG for dark skin. Here at Dolce Aesthetics we use the Cynosure Apogee Elite, which is the gold standard of lasers.
1. Find a reputable laser office, with a certified experienced laser tech.
2. Make sure you are treated with the proper laser.
3. Follow your laser tech’s rules for pretreatment and post treatment.
4. Do not wax, tweeze, thread or pluck at all when doing laser treatments ( for best results).
5. Keep to the appointments that your laser tech gives you for effective hair loss results.
Laser hair removal is a safe, effective way to remove your hair and be shave free for years.