Diluted Radiesse to Tighten Skin on the Face and Body

 Diluted Radiesse to Tighten Skin on the Face and Body | RealSelf News

Chances are, you’re familiar with Radiesse. Since gaining FDA approval in 2006, some 6 million syringes of the filler have been injected deep in the skin, to restore lost volume and correct facial wrinkles and folds. Radiesse is frequently used to smooth smile lines, lift sunken cheeks, plump hands, and strengthen jawlines.

Recently, however, dermatologists and facial plastic surgeons have started using Radiesse in a unique way, by diluting (or when the ratio is 1:2 or higher, hyperdiluting) it with saline or lidocaine and injecting it more superficially, to address concerns related to skin texture and laxity—think fine wrinkles, crepiness, acne scars, and cellulite as well as saggy skin. It’s being used on the face, neck, chest, arms, abdomen, legs, and buttocks. 

“I love this technique,” says Dr. Jessie Cheung, a board-certified dermatologist in New York City and Chicago. “We’re not adding volume, but we see the skin tighten and shrink and become smoother.”

Interested in Radiesse?

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Radiesse vs. diluted Radiesse—what’s the difference?

A little refresher course on Radiesse: unlike hyaluronic acid (HA)–based filling materials like Juvéderm and Restylane, Radiesse works by stimulating your body to make collagen, the protein that plumps skin and keeps it smooth. The filler is made up of microspheres of calcium hydroxyapatite (CaHA), a substance also found in bones, that are suspended in a gel.

Like HA fillers, Radiesse works immediately to improve the treated area. But over time, the gel is fully absorbed and the body metabolizes the CaHA microspheres, leaving behind your own natural collagen, which lasts for 18–24 months. “In its unaltered form, Radiesse holds up well against gravity, which makes it an excellent filler for areas requiring a significant amount of structure and/or that are impacted by strong muscles, like the cheeks and jawline,” explains Dr. Heidi Waldorf, a board-certified dermatologist in Nanuet, New York, who was on the consensus panel that determined the preliminary guidelines for using hyperdiluted Radiesse.

Depending on how much Radiesse is diluted, the material has a mild volumizing effect, at best. Instead, it creates the equivalent of a gel mesh. “This initially holds an area more taut, but over time, it acts primarily as a biostimulator to improve the tone and texture and even tighten skin,” explains Dr. Waldorf. She uses it most commonly for the cheeks, neck, and chest in patients who have severe “solar elastosis,” or damaged collagen and elastin from sun exposure.

Tighten and smooth, from the neck down

This technique has been used in Europe for a few years, but it’s catching on more in the U.S. and should be widely adopted in 12–18 months, says Dr. Steven Weiner, a facial plastic surgeon in Santa Rosa Beach, Florida. He’s particularly a fan of using diluted Radiesse to treat “off-face” areas that weren’t being addressed completely with other modalities and “now can be treated with significant improvement, with minimal to no downtime and [few to no] risks.”

He uses it mostly for necks, on patients with mild to moderate laxity, as part of his Tri-NECK-ta treatment, which also includes Dysport (a botulinum toxin); Genius (radiofrequency microneedling, or RFM); or laser resurfacing. “I often inject Radiesse in the neck in combination with the Genius to improve wrinkles and skin integrity, and it actually tightens the skin, with or without RFM,” he says. Indeed, in one small study on the neck and décolletage, injections of diluted Radiesse stimulated significant amounts of collagen. The treatment, researchers concluded, was very effective for skin tightening in both areas.

Related: Hyaluronic Acid vs. Biostimulatory Fillers: What to Know Before You Get Injected

How diluted is diluted Radiesse?

Many experts have developed techniques for diluting CaHA, in ratios of anywhere from 1:1 to 1:6. Dilutions can be adjusted, depending on the thickness of a patient’s skin and the degree of tissue laxity, to ensure smooth placement. If not properly diluted, the material can look bumpy, especially if it’s injected too superficially. In one study where hyperdiluted Radiesse was used on the neck, researchers injected different dilutions based on skin thickness: 1:2 (normal skin), 1:4 (thin skin) and 1:6 (severely “atrophic” or aged skin).  

Diluted Radiesse is injected with a cannula or needle, with or without topical anesthetic, depending on whether Radiesse or Radiesse (+), which contains the anesthetic lidocaine, is used. Several injection techniques are used: for skin laxity, multiple cannula passages are made in patterns that resemble a fan or an asterisk. The material can also be injected in short, linear “threads.”  

As a bonus, the dilution eases the filler delivery for the injector. It also reduces filler thickness and facilitates its even spread, encouraging skin stimulation through more direct contact with tissues and minimizing unevenness. 

As with any filler injection, there can be a variable amount of bruising and swelling, which normally lasts up to a week. “Although uncommon because of the thinning of the product, if a bump is seen or felt after swelling and bruising have resolved, it can be camouflaged with other filler or broken up with injection and massage,” says Dr. Waldorf.

When injecting diluted Radiesse, less is more to prevent excess swelling, especially when using higher dilutions, says Dr. Waldorf. For instance, when treating the neck, she’ll often use one syringe of Radiesse and then have the patient return in two to four weeks for another treatment. 

Interested in Radiesse?

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The “add-on” effect

Diluted Radiesse can be used alone, “but harder-to-treat concerns, like the neck, chest, and arms, invariably do best with a combination approach,” explains Dr. Waldorf. She says diluted Radiesse is a great adjunct to other tightening and resurfacing procedures, like Ultherapy, Thermage, and Fraxel, because they work together to improve dermal collagen. “Think of combination therapy like assembling an outfit—each piece of the outfit does something different, and together they make the look.” 

That said, in one study that evaluated the effectiveness of diluted Radiesse used by itself to tighten skin in the upper arms and abdomen, skin thickness significantly increased after a single treatment and 90% of participants and physicians rated the areas very much improved.

Diluted Radiesse is frequently also combined with traditional Radiesse injections. “Most patients want the straight filler effect,” says Dr. Cheung. “Spackling” or “frosting,” as she called treatment with diluted Radiesse, is additional. “You see the effects of the regular filler immediately and then see the collagen that diluted Radiesse stimulates after about a month,” Dr. Cheung explains. “Patients look good from the filler right away, then come back and say their skin looks tighter [and] smoother and that they look a little more lifted.” 

How much diluted Radiesse is needed, and what does it cost?

Radiesse is available by the syringe, and, according to the current practice guidelines, treatment typically requires one to two syringes. The face and neck each usually require a single 1.5cc syringe per session, while the chest requires a half to a full syringe. The buttocks require one syringe per cheek (for cellulite and sagging skin), and the thighs need one syringe per thigh area (inner or outer). The abdomen requires two syringes, one each for the upper and lower half. The knees and elbows require one syringe in total (half on each side), and the arms usually need between a half and a full syringe per arm. Usually, two sessions for fillers are necessary, spaced one or two months apart. 

Depending on what’s being treated, the treatment may be repeated at six months or a year. Preliminary research shows that results with diluted Radiesse may last up to two years. 

The average cost paid for Radiesse by RealSelf members is $1,050 per treatment. 

Source Revance Announces FDA Approval of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results | Business Wire 

NASHVILLE, Tenn.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.1 DAXXIFY™ is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components.1-2,7-11 Most importantly, DAXXIFY™ has the ability to address duration of treatment effect, which we believe is the greatest unmet need with existing neuromodulators for both consumers and injectors.12 The FDA approval, Revance’s first, augments the company’s innovative aesthetics portfolio and expands the company’s access to the growing $3.2 billion U.S. facial injectables market, further establishing Revance as an innovation leader in the industry and laying the groundwork for potential future therapeutic indications.13

“With DAXXIFY’s innovative and differentiated performance profile, alongside our portfolio that includes the RHA® Collection of dermal fillers and the OPUL® Relational Commerce platform, we have a real opportunity to build on our commercial success while setting a new standard for neuromodulator formulation”

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“The FDA approval of DAXXIFY™ is a foundational achievement for the company as it marks the culmination of years of pioneering research and development made possible by the outstanding execution of our talented team, along with strong support from the medical and investor communities. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years,” said Mark J. Foley, Chief Executive Officer. “Importantly, we are very pleased DAXXIFY™’s label includes data demonstrating the achievement of none or mild wrinkle severity based on investigator and subject assessments, as this provides the foundation for our marketing claims around duration of effect. We look forward to continuing to set new standards in aesthetics and to establishing a new category of long-lasting, peptide-enhanced neuromodulators.1,11”

Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, commented, “As a SAKURA investigator, I’m pleased to see DAXXIFY™ now approved as the first and only peptide-formulated, long-acting neuromodulator in the market. Compelling data from the largest Phase 3 clinical program ever conducted for glabellar lines demonstrated that DAXXIFY™ was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, DAXXIFY™ was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines. With today’s approval, I look forward to helping patients, who have been accustomed to a 3 to 4-month duration profile with conventional neuromodulators, achieve year-long results with as few as two treatments per year.2-5 *”

The U.S. approval of DAXXIFY™ was based on the data generated in the SAKURA Phase 3 clinical trial program (SAKURA 1,2,3), which included more than 2,700 patients and approximately 4,200 treatments. In the pivotal trials:

• 74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment1,4¶
• 88% achieved > two-grade improvement at week 4 per investigator assessment1¶
• 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment 4¶
• 6-month median duration3,4*
• Some patients maintained treatment results at 9 months2-4‡
• Results seen as early as one day after treatment, typically seen within two days14¶

DAXXIFY™ is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety profile consistent with other currently available neuromodulators in the aesthetics market.1-5,7-10 The most common treatment-related adverse events with DAXXIFY™ observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).1

“With DAXXIFY’s innovative and differentiated performance profile, alongside our portfolio that includes the RHA® Collection of dermal fillers and the OPUL® Relational Commerce platform, we have a real opportunity to build on our commercial success while setting a new standard for neuromodulator formulation,” said Dustin S. Sjuts, President. “The strong inroads that we have made in the prestige market with our products and services will serve as a solid foundation upon which to launch DAXXIFY™. Consistent with our commercial strategy, DAXXIFY™ will be available through Revance Aesthetics’ elite partners, known for delivering exceptional consumer outcomes and experiences. We are excited to be launching DAXXIFY™ shortly with an early training and education program at our world-class headquarters and experience center in Nashville, followed by a broader commercial launch.”

Practices interested in receiving more information on DAXXIFY™ may reserve their spot at RevanceAesthetics.com.

Understanding Filler Rheology for Safer, More Attractive Injections Understanding the physicochemical properties of the different dermal fillers will help you deliver safer and more attractive outcomes.

Article Credit : Understanding Filler Rheology for Safer More Attractive Injections | MedEsthetics (medestheticsmag.com)

By Inga Hansen 

 In the past two decades, the number of dermal fillers in the U.S. market has increased by more than 100%, and consumer demand for these treatments has skyrocketed. Key to achieving optimal outcomes is understanding different fillers’ unique physicochemical properties and how that affects their behavior in the skin. “There are a lot of different words we use to describe filler properties: stretch, strength, lift and flexibility are just some of them. It doesn’t matter what you call them, you just need to know what goes where,” says Carolyn Jacob, MD, medical director of Chicago Cosmetic Surgery and Dermatology.

The core measure that injectors need to understand when determining which filler is most appropriate for specific anatomical regions is the filler’s rheology—how the material deforms and changes under mechanical stress. For “Rheologic properties of soft tissue fillers and implications for clinical use” (Journal of Cosmetic Dermatology, January 2021), Nazanin Saedi, MD, of the department of dermatology and cutaneous biology at Thomas Jefferson University in Philadelphia and colleagues compared the rheology of a wide range of dermal fillers.

They noted that the rheology of hyaluronic acid (HA) fillers is determined by the degree of cross-linking, HA particle size, gel concentration and length of the HA chains, with cross-linking and particle size being the key characteristics that define a filler’s behavior under mechanical stress.

“We often talk about high G’ when you want lift and volume, such as in the cheeks and jawline. But G’ isn’t everything when it comes to rheology and lifting capacity,” says Dr. Saedi. “Things to look at also are cohesivity and particle size. A lot of the Juvederm products have a lower G’, but they have more cross-linking so they’re more cohesive and can provide volume that way. Whereas some of the Restylane fillers use larger particle sizes of HA to provide lift. So, we need to understand that cross-linking, particle size and gel concentration all play a role.”

Filler Selection and Indications

Fillers such as Radiesse, Restylane Lyft and Juvederm Voluma XC offer the greatest lift and lowest risk of deformity against mechanical stress. They should not be injected superficially or in areas with a lot of mobility as they will create noticeable bumps, especially during facial movement. They do offer superior revolumization when used in the midface, jawline or hands. “Ten years ago, all we had were medium and low G’ fillers, so we had to put a lot of filler in the face to get volume and lift, and it did not look natural,” says Mariano Busso, MD, a dermatologist with practices in Miami, Florida and Beverly Hills, California. “These fillers allow you to get the most amount of lift with the least amount of product.”

Proper injection technique when performing deep injections in the cheeks to revolumize will help reduce the risk of granulomas and uneven volumization. “If you inject a lot of filler at once, it can be uneven,” says Dr. Busso. “But if you inject small amounts in tracks around the zygomatic bone laterally or superiorly for cheeks, for example, you nicely distribute the filler.”

Tetracycline Injections for Undereye Festoons

 A long-term follow-up study of patients who underwent teatracyline injections for festoons revealed that 59% of patients saw improvement and 67% would repeat the procedure. Authors Brian H. Chon, MD, Catherine J, Hwang, MD, and Julian D. Perry, MD, of the Cole Eye Institute, Cleveland Clinic Foundation, invited all patients undergoing tetracycline injection for treatment of lower eyelid festoons at the Cole Eye Institute, Cleveland Clinic, between 2008 and 2018 to participate in a questionnaire based on the FACE-Q checklist.

Of 102 patients who received tetracycline injection during the study period, 61 responsed to the questionnaire. The average follow-up time after injection was 3.6 years. Of the 61 respondents, 36 (59%) noted improvement in their festoons after treatment, and 27 of 33 noted that improvement occurred within two months of treatment. Overall, 40 of 60 respondents (67%) responded that they would consider repeating tetracycline treatment.

The most common adverse effects included discomfort (18%), swelling (15%) and bruising (13%). The authors noted that, although the majority of patients experienced improvement with an acceptable side-effect profile, “more data are needed to determine the optimal dose and frequency and to identify possible rare and/or significant side effects.”

The study, "Long-Term Patient Experience with Tetracycline Injections for Festoons," was published in Plastic and Reconstructive Surgery (December 2020).

Source 

Tetracycline Injections for Undereye Festoons | MedEsthetics (medestheticsmag.com)

Microneedling with Tranexamic Acid as Effective as 4% Hydroquinone for Melasma

 Patients with dermal melasma benefit from combination treatment with microneedling plus topical application of 4% tranexamic acid, according to a randomized study published in the November 2020 issue of the Journal of Cosmetic Dermatology. 

Authors Simin Shamsi Meymandi, MD, et al, of Kerman University of Medical Sciences, Kerman, Iran, evaluated the efficacy of microneedling plus tranexamic acid in comparison with 4% hydroquinone in the treatment of melasma. They treated 70 patients with melasma (60 patients completed the study), who were randomized based on simple randomization into two groups. Group A (30 patients) underwent monthly microneedling plus topical 4% tranexamic acid. Group B (30 patients) applied a topical 4% hydroquinone product nightly. The researchers evaluated melasma area severity and index (MASI) scores and patient satisfaction at baseline, four weeks, eight weeks and 12 weeks.

At the end of treatment, the mean MASI score was significantly lower in both groups with no statistical difference between two groups. Mean MASI score in group A was significantly lower at the end of the treatment (6.84 ± 4.31) than at the baseline (12.89 ± 5.16). Mean MASI score in group B was significantly lower at the end of the treatment (7.16 ± 4.38) than at the baseline (13.56 ± 4.88). The percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups.

Article Source 

Microneedling with Tranexamic Acid as Effective as 4% Hydroquinone for Melasma | MedEsthetics (medestheticsmag.com)

Vertical Glabellar Line Fillers and the Supratrochlear and Supraorbital Arteries “The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected.”

 Source : research/injectables/news/21206867/understanding-the-location-of-vertical-glabellar-lines-and-the-supratrochlear-and-supraorbital-arteries

In an effort to reduce the risk of complications following glabellar soft tissue filler injections, researchers Sebastian Cotofana, MD, PhD, et al, used ultrasound imaging to identify the course of the superficial branch of the supratrochlear artery and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line. They measured the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning.

After analyzing 41 healthy volunteers (mean age of 26.17 years and mean BMI of 23.09 kg/m2), they found that the mean depth of the supratrochlear artery was 3.34mm at rest and the mean depth of the supraorbital artery was 3.54mm.

The location of the arteries varied by gender: The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59mm in males and 8.21mm in females. The mean distance between the supraorbital artery and the ipsilateral vertical glabellar line was 22.38mm for in males and 20.73mm in females.

Upon frowning, there was a medial shift in the position of the supratrochlear arterial of 1.63mm in males and 1.84mm in females and a shift of 3.9mm in supraorbital arterial position for both genders .

The authors of the study, published in the Aesthetic Surgery Journal (December 2020), concluded, “The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.”

FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls

 In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued a warning letter and added five entries to its 'do not use' sanitizer list over product sub-potency. It also flagged four foaming hand soaps recalled for possible microbe contamination.

See related: 900+ Hand Sanitizer Poisonings, Mexican Imports Put on FDA Alert

Warning Letter: Insufficient (58%) Ethanol Content

A warning letter issued on Feb. 18, 2021, to Absaea Cosmetics, of Emiliano Zapata, Mexico, the FDA states, "Following an attempt to import Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free Formulated with 70% of Alcohol with Aloe Vera & Glycerin into the United States, it was detained and refused admission at the border. The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated ... in that its strength, purity, or quality falls below that which it purports or is represented to possess."

See related: How NOT to Formulate Hand Sanitizers

The agency outlined that the product is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA testing found that the drug product contained only 58% v/v ethanol. "This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the products lower than that which is declared on its labeling," the letter states.

The FDA concluded that all drugs and drug products manufactured by the firm remain listed on import alert until there is evidence establishing that the conditions that gave rise to the violation have been resolved.

Hand Sanitizer Additions to 'Do Not Use' List

Continuing its monitoring for hand sanitizer violations, the FDA added five listings to its hotlist of products consumers are warned not to use. The agency noted it currently has no evidence of these products being on the U.S. market, but all of the following were flagged for subpotent alcohol (ethanol) levels: two listings for Weper Clean Solutions, Kleengel Hand Sanitizer, CyroLab Q&T Antibacterial Gel and Kilvir Forte Virus Killer, all manufactured by Distribuidora Lagunera del Norte SA de CV, of Mexico.

Possible Burkholderia cepacia Contamination

Finally, four voluntary product recalls were made by Scent Theory Products for potential Burkholderia cepacia contamination. These included four foaming hand soaps made with essential oils: Lemon Citrus, Vanilla Coconut, Eucalyptus Mint and Fresh Lavender.

Source Article FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls | MedEsthetics (medestheticsmag.com)