With the entry of Letybo (letibotulinumtoxinA), from Hugel Aesthetics, into the U.S. aesthetic market, physicians and patients alike are beginning to evaluate how this botulinum toxin, which received FDA approval last year, stacks up against long-established brands. Plastic Surgery Practice spoke with Donald Yoo, MD, a double board certified facial plastic surgeon based in Beverly Hills, Calif, about his clinical experience with the product. Yoo also discusses Persana, a tech platform aimed at streamlining access to injectables by simplifying ordering, inventory management, and patient engagement. Having gained significant traction in Asia and Europe, Letybo now faces the challenge of earning trust in a brand-saturated American market.

Plastic Surgery Practice: Letybo is being positioned as a high-purity, smooth-diffusing botulinum toxin with long-lasting results. Based on your expertise and experience, how does it compare to established brands in terms of efficacy and patient outcomes?

Donald Yoo, MD: Letybo has been the number one neuromodulator in the Korean cosmetic market for the past 7 years, and has sold over 26 million vials in Asia, Europe, and Australia, and during that time has demonstrated an outstanding safety profile. Its positioning as a high-purity, smooth-diffusing botulinum toxin aligns with clinical observations of a natural, soft finish. In my experience, it performs on par with more established neurotoxins in terms of duration—around 3 to 4 months. Onset appears slightly quicker than Botox, with observable effects within a few days rather than the one-to-two-week timeline with Botox. This is in line with competitors such as Dysport.

PSP: With Letybo’s growing presence in Europe and China, but relatively low awareness in the United States, what challenges and opportunities do you see for its adoption in the American aesthetic market?

Yoo: The U.S. neuromodulator market is extremely competitive and heavily brand-driven, so Letybo’s biggest challenge will be building trust, name-recognition and awareness among both providers and patients. However, the opportunity lies in its already established and continually growing international credibility—especially in markets like Korea and Asia, where innovation in aesthetics is often ahead of the curve. If supported by solid clinical data, transparent education, and competitive pricing, Letybo could become a strong alternative for providers seeking to diversify or optimize results.

PSP: Every botulinum toxin has unique properties that influence how it spreads, how quickly it takes effect, and how long it lasts. Have you observed any distinct differences with Letybo that could make it particularly suited—or unsuited—for certain patient needs?

Yoo: Yes. Every neurotoxin has its own diffusion profile and onset characteristics due to the differential accessory proteins they carry surrounding the botulinum core protein they all share in common. Letybo seems to diffuse smoothly and evenly, making it well-suited for fine-line work or areas where precision and subtlety matter, like the forehead or crow’s feet. In the three FDA clinical trials it underwent with over 1200 patients, it showed itself to be just as effective as Botox for the glabella or frown lines. Due to its effectiveness and outstanding safety profile it certainly earns its place in a well-rounded injectable portfolio. Some patients who have developed Botox resistance or developed neutralizing antibodies to other neuromodulators may benefit from trying a slightly different formulation like Letybo.

PSP: Pricing and accessibility often play a role in product adoption. Given the rise of platforms like Persana that are streamlining access to injectables, how do you see tech-driven beauty services influencing the neurotoxin landscape? 

Yoo: As a Persana-verified physician, I’ve seen firsthand how innovative tech platforms like Persana are transforming the industry by making access to injectables more seamless. By streamlining ordering, optimizing inventory management, and enhancing patient engagement, these platforms reduce friction and empower providers to deliver more efficient, accessible care.

PSP: Many patients are brand loyal when it comes to injectables. What would you say to doctors who are hesitant to add a new option to their offerings? Are there any specific cases where you might recommend it over other options?

Yoo: Skepticism is natural, especially in a market where patient trust and outcomes are everything. That said, innovation always starts with curiosity and careful observation. I’d encourage providers to try Letybo in controlled, low-risk cases—perhaps with patients seeking a softer or more natural aesthetic, or cases of Botox resistance—and compare results firsthand. The more options we have, the better we can personalize care. In some cases, Letybo may offer a better fit for a patient’s goals, and being able to offer that option is a strength, not a risk. PSP

Main image photo credit: ID 182830119 © Viacheslav Iacobchuk | Dreamstime.com

Shanghai Moyom Biotechnology has obtained a Class III Medical Device Certificate from the China National Medical Products Administration (NMPA 20253130390) for its Aphranel MagiCCrystal CaHA filler.

The company says this makes it the first calcium hydroxylapatite microsphere (CaHA) injectable product approved in China for facial soft tissue augmentation. CaHA microspheres have become a core material in the global biostimulating injection field due to their biocompatibility and biodegradability, the company notes in a release. 

Leveraging proprietary technology, Moyom has controlled CaHA microsphere size (30-35μm), through-hole structure, and degradation rate to develop the Aphranel MagiCCrystal CaHA filler. “Its raspberry-like through-hole design increases porosity by 40%, with the number of microspheres per unit volume exceeding six times that of competing product. The viscoelastic modulus (G’ value) reaches 5500Pa, enabling long-lasting 3D supporting effect,” according to a release from the company.

The product employs a pre-mixing technology combining CaHA and carboxymethyl cellulose to ensure uniform particle suspension and a smoother injection push force. Validated by 31 biochemical tests, its inflammation rate is 30% lower than leading standards, and it is fully biodegradable. Its safety has been certified by Notified bodies in the EU, Brazil, Russia, Saudi Arabia, Mexico, and other countries.

“We are committed to providing safer and more accessible products for the global medical aesthetics market through technological innovation and promoting the sustainable development of the industry,” according to a release from the company.

Photo caption: Aphranel MagiCCrystal CaHA filler

Photo credit: Shanghai Moyom Biotechnology

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Galderma will present new data from across its portfolio, including Relfydess, Sculptra, and Restalyne, while also presenting results from a survey on facial changes caused by medication-driven weight loss at the 23rd Aesthetic & Anti-Aging Medicine World Congress in Monaco from March 27-29, 2025.

In total, Galderma will present 11 e-posters, host two symposia, four Masterclass sessions, five Meet-the-Expert sessions, and host an experiential lounge and interactive booth.  

“Through our data presentations and expert-led sessions, we reaffirm our commitment to being a leading force in advancing the field of Injectable Aesthetics and equipping healthcare professionals with the innovative solutions they need to fulfill the needs of patients, today and tomorrow,” says Baldo Scassellati Sforzolini, MD, PhD, head of global research and development at Galderma, in a release.  

Impact of Medication-driven Weight Loss

Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with alterations in facial aesthetic appearance of variable magnitude. In a study investigating facial changes in medication-driven weight loss to date, Galderma surveyed more than 1,300 people across five countries. Findings from this study will be presented, showing 93% of those undergoing weight loss treatment noticed some degree of facial changes during their treatment, and many patients are considering aesthetic treatments to address these, with biostimulators and dermal fillers being the most frequently considered treatments.

The Galderma-sponsored “Medication-Driven Weight Loss: The Algorithms” symposium taking place on Thursday, March 27, as well as a dedicated Masterclass session on Friday, March 28, will explore the effects medication-driven weight loss can have on the face and dive into the ways aesthetic procedures can help restore facial volume and structure. 

New Data on Relfydess, Sculptra, and Restylane Shaype

Relfydess

Galderma will present new data from the phase IIIb EXPRESSION and RELAX studies, showing Relfydess achieved rapid onset of action and significant aesthetic improvement in frown lines and crow’s feet. 

In the EXPRESSION study, more than 50% of patients reported visible effects as early as day one and, in the RELAX study, effects were sustained through six months, confirming results seen in the READY trial program, and more than a third saw improvement beyond six months in frown lines.

Both studies re-confirmed high patient satisfaction with Relfydess, with 70% of patients in the RELAX study reporting that they preferred treatment with Relfydess versus prior treatments received. Encore data from a post-hoc analysis of the phase III READY program will show that, regardless of baseline wrinkle severity (moderate/severe), subjects treated with Relfydess achieved high rates of improvement in frown lines and crow’s feet, along with improved well-being, and a sustained effect through six months.

Sculptra

Galderma will also present new data on Sculptra (PLLA-SCA), a regenerative biostimulator, reinforcing its formulation, efficacy, and safety. New in vivo comparative data will demonstrate its favorable tissue response and slower, controlled product degradation profile at 52 weeks, as well as lower inflammation, compared to PLLA-GA. The lower inflammation is consistent with Sculptra’s safety profile. Differences in formulation can significantly impact local tissue response and product degradation, affecting potential clinical outcomes such as efficacy and duration.

An expert consensus also confirms Sculptra’s key role in the regenerative aesthetic field, and additional data will show its synergistic effect when paired with Alastin, underscoring its effect across all three skin layers.

Restylane Shaype

Encore data to be presented on Restylane Shaype, powered by Galderma’s proprietary NASHA HD Technology and approved in Canada and most recently in Brazil, will show that it constitutes an innovation in hyaluronic acid fillers as the firmest hyaluronic acid injectable available and displaying the highest G-prime (indicating superior gel strength and firmness) on the market providing a unique bone mimicking effect. 

Additional pooled and pivotal phase IV data to be presented will show that Restylane fillers preserve or enhance the natural expressions of 98% of patients while achieving desired aesthetic improvements in attractiveness and youthfulness. This naturalness, combined with high patient satisfaction, represents long-lasting aesthetic improvement. 

These e-posters, along with others presented on Dysport and Alastin, will be available. 

ID 24863104 © Robert Kneschke | Dreamstime.com

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Key Takeaways:

• PACE Academy offers hands-on training with digital cadaver technology and evidence-based courses on injectables.
• The initiative provides Harley Academy students with specialized instruction on Prollenium’s Revanesse dermal fillers.

Prollenium, a medical technology company, announced the launch of PACE Academy (Prollenium Advanced Clinical Education), a 5,000-square-foot facility dedicated to advanced training and education in medical aesthetics. According to the company, this initiative marks a first-of-its-kind partnership with Harley Academy, a world leader in higher education for aesthetic medicine.

Situated on Prollenium’s campus in Richmond Hill, Ontario, PACE aims to foster collaboration among key opinion leaders, medical injectors, and industry professionals. The academy is equipped with innovative learning tools, including an Anatomage table with digitized cadavers—the first interactive technology of its kind available outside universities and hospitals, according to the company. PACE also offers exclusive access to Prollenium’s manufacturing facility, the only site in North America producing hyaluronic acid (HA) dermal fillers.

In a press release, Prollenium states that Harley Academy brings unparalleled expertise to PACE with evidence-based courses on injectables and cosmetic dermatology. The curriculum blends their training model—physician-led instruction, personalized mentoring, and a mix of online and hands-on sessions—with PACE’s advanced tech environment. This partnership also features dedicated training sessions for Harley Academy students on Prollenium’s Revanesse range of dermal fillers.

“The opening of PACE marks a significant milestone for Prollenium, bridging a crucial gap in the industry where professionals can engage with groundbreaking technology and elevate their expertise,” said Ario Khoshbin, founder of Prollenium.

“PACE is designed to integrate with the technology and science we’ve developed and provide unprecedented access to advanced tools,” Khoshbin added.

Photo: Business Wire

Key Takeaways

• The approval of Evolysse Form and Evolysse Smooth transitions Evolus from a single-product company to a multi-product aesthetics innovator.
• In head-to-head trials, Evolysse fillers showed statistically significant advantages over Restylane-L in longevity and effectiveness.
• Evolus is expanding beyond the U.S. with a European launch of the Estyme dermal filler line set for late 2025.

Evolus Inc, a beauty company focused on building an aesthetic portfolio, announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse collection. These approvals mark Evolus’ entry into the U.S. HA dermal filler market and expansion as a mutli-product aesthetics company. 

Company Leadership Highlights Market Impact

“This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty,” said David Moatazedi, president and CEO of Evolus. “Evolysse Form and Evolysse Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation. The launch of these products is a catalyst in our growth as we are focused on achieving at least $700 million in net revenue and non-GAAP operating income margin of at least 20% by 2028.”

U.S. Market Launch Planned for 2025

Evolus plans to launch Evolysse Form and Evolysse Smooth in the U.S. market in Q2 2025. According to a press release from the company, this launch will leverage Evolus’ scalable cash-pay business model and existing digital infrastructure, creating tremendous synergy with the company’s fast-growing neurotoxin business and driving significant value for both customers and consumers. 

Cold-X Technology

Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes Cold-X technology that reportedly is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. The commercial launch of these first two injectable HA gels in 2025 will be followed by Evolysse Sculpt in 2026, and Evolysse Lips in 2027.

Industry Partnerships and Clinical Validation

“We are proud to partner with Evolus in bringing the Evolysse collection of injectable HA gels to the U.S. market. With decades of experience in biomaterial science and aesthetics, Symatese has a strong legacy of developing innovative aesthetic products that meet the evolving needs of practitioners and their patients. With one of the largest clinical trial programs undertaken for an injectable HA technology, Evolysse products are being evaluated for safety and effectiveness in over 2,000 patients globally,” said Jean-Paul Gérardin, CEO of Symatese.

FDA Approval and Clinical Outcomes

Dr Rui Avelar, Evolus chief  medical officer and head of R&D, added, “The FDA approval of Evolysse Form and Evolysse Smooth reflects our commitment to bringing high-quality, innovative aesthetic products to market. These additions to our portfolio reinforce Evolus’ dedication to the highest standards of patient safety and efficacy. With the introduction of Cold-X technology, Evolysse offers a differentiated approach to the dermal filler category, providing healthcare practitioners with new options to address the unique needs of their patients with precision and confidence.”

U.S. NLF Pivotal Study

Michael Kaminer, MD, lead investigator for the U.S. NLF pivotal study and an internationally recognized expert in cosmetic surgery, commented, “The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity.” 

The U.S. Nasolabial Fold (NLF) pivotal study for Evolysse Form and Evolysse Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. According to the company, 70 patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

Head-to-Head Study

Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority.

As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at 6 and 9 months—even though 20% more Restylane-L was used.

According to the company, in the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.

Global Expansion Plans: Estyme in Europe

Evolus previously announced that EU Medical Device Regulation (MDR) approval was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme. Evolus is also introducing Estyme through a limited experience program with select physician partners in Europe, to continue to expand global experience with the product’s performance. A broader European launch remains on track for the second half of 2025, further expanding Evolus’ footprint into the global dermal filler market and reinforcing its position as a leader in performance beauty.

Photo: ID 354157505 © Dmytro Dudchenko | Dreamstime.com

Summary

The FDA has approved Evolysse Form and Evolysse Smooth, marking Evolus’ entry into the US HA filler market. These injectable hyaluronic acid (HA) gels, developed by Symatese, utilize Cold-X technology to better preserve the HA molecule’s natural structure for longer-lasting, natural-looking results. A head-to-head clinical trial compared Evolysse Form and Evolysse Smooth to Restylane-L, finding that Evolysse Form was statistically superior at all measured time points over 12 months, while Evolysse Smooth was superior at six and nine months, even though 20% more Restylane-L was used. The safety profile of both fillers was comparable to Restylane-L, with no treatment-related serious adverse events or delayed-onset nodules. Evolus plans to launch the products in Q2 2025.

Key Takeaways

1. FDA Approves Evolysse Form and Evolysse Smooth – Evolus has received FDA approval for its first HA dermal fillers, developed in partnership with Symatese and featuring Cold-X technology for enhanced longevity.
2. Head-to-Head Trial Shows Superiority Over Restylane-L – Evolysse Form demonstrated statistical superiority at all time points over 12 months, while Evolysse Smooth was superior at six and nine months, even with less product used.
3. Evolysse Collection Set to Launch in Q2 2025 – Evolus will introduce its HA filler line to the US market later this year.

Evolus Inc announced that the US Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse collection, marking the company’s entry into the US HA dermal filler market.

Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes innovative Cold-X technology that is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. 

“Evolysse Form and Evolysse Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation,” says David Moatazedi, president and chief executive officer of Evolus, in a release.

Head-to-Head Study With Restylane-L

The US Nasolabial Fold pivotal study for Evolysse Form and Evolysse Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. Seventy patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority.

As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured time points for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at six and nine months, even though 20% more Restylane-L was used.

In the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.

Michael Kaminer, MD, lead investigator for the US NLF pivotal study, says in a release, “The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with their effectiveness and longevity.”

Evolus plans to launch Evolysse Form and Evolysse Smooth in the US market in Q2 2025.

Photo caption: Evolysse Form and Evolysse Smooth

Photo credit: Evolus

Plastic Surgery Practice: How does the safety profile of RelabotulinumtoxinA in the READY-4 trial compare with previous neuromodulators used for frown lines and crow’s feet?

Baldo Scassellati Sforzolini, MD, PhD, MBA: These first results from the phase III READY-4 trial demonstrate the long-term safety of repeated injections of RelabotulinumtoxinA for both frown lines and crow’s feet, with efficacy and patient satisfaction maintained across multiple treatments. These data build on the results from the READY-1-3 studies, in which RelabotulinumtoxinA also demonstrated a favorable safety profile and a low incidence of treatment-related adverse events.

As the first neuromodulator developed and manufactured by Galderma, RelabotulinumtoxinA adds to the growing body of evidence supporting its safety and efficacy. We are proud to contribute to the latest innovations in aesthetics, reaffirming our commitment to bringing the best advancements to the market.

PSP: What factors ensure RelabotulinumtoxinA’s six-month efficacy in the READY trial? How does its day-one onset enhance patient outcomes?

Sforzolini: In the neuromodulator space, patients seek fast and sustained results, and healthcare professionals look for longer-lasting, more convenient, and ready-to-use solutions. RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dosing. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology, designed to preserve molecule integrity to deliver fast and sustained results for frown lines and crow’s feet.

In READY-1 and READY-2, 39% of patients reported improvements for frown lines and 34% reported improvements for crow’s feet from day one. In READY-1, 75% of patients maintained improvements for six months, as measured by a Kaplan-Meier analysis of the time to return to baseline on both the investigator and subject scales. At month one, up to 96% achieved no or mild frown lines and crow’s feet, which was sustained for six months in almost a quarter of patients.

PSP: Could you explain the role of PEARL Technology in preserving the molecule integrity of RelabotulinumtoxinA?

Sforzolini: Precipitation-free Extraction and Activity-Preserving Refined Liquid (PEARL™) Technology is a pioneering approach proprietary to Galderma and has been over 15 years in the making, designed to preserve the power and natural form of the core molecule.

This advanced technology, with a unique multi-step purification process, eliminates precipitation and freeze-drying steps associated with traditional methods, keeping the core molecule in a liquid state throughout. It is designed to carefully remove complexing proteins and impurities while preserving RelabotulinumtoxinA’s potency and natural structure, aiming to optimize both activity and purity to produce a highly active formulation containing only the essentials.

PSP: What were the key findings from the post-hoc analysis showing RelabotulinumtoxinA’s efficacy across diverse populations in the READY-1, -2, and -3 studies?

Sforzolini: Pooled data from a post-hoc analysis of the READY-1, -2, and -3 studies showed similarly high rates of improvement for both frown lines and crow’s feet following treatment with RelabotulinumtoxinA across different skin types, ethnicities, and races. The treatment was also well tolerated in all subgroups.

These data add to the robust body of evidence demonstrating the efficacy and safety of RelabotulinumtoxinA, reinforcing its effectiveness across diverse populations and highlighting its potential to advance the neuromodulator space by addressing and surpassing current treatment limitations.

References:

1. Galderma. Data on file. Clinical Study Report for Protocol 43QM1602: READY-1. Galderma Laboratories; 2021Galderma.
2. Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021
3. Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthetic Surgery Journal. 2024; sjae131
4. Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin

Key Takeaways:

1. Higher Botox Dosage Required in Sunnier Climates: The study indicates that individuals in “high-sun” environments, like Malta, may need more Botox to achieve similar levels of muscle paralysis compared to those in less sunny settings, such as London, due to increased muscle activation from squinting and possibly higher temperatures.
2. Adjustments to Treatment Protocols: Plastic surgeons may need to modify their standard Botox dosing protocols to consider the climatic conditions of their practice locations to ensure effective and consistent cosmetic results.
3. Implications for Training and Treatment Costs: Although the differences in dosage requirements are small, they are significant enough to suggest that standardized treatment protocols may lead to under-treatment in sunnier climates, affecting both the training of practitioners and the predictability of treatment outcomes.

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Patients living in “high-sun” climates may require higher doses of Botox to achieve good results in the cosmetic treatment of facial lines and wrinkles, reports a study in the July issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

“In countries with higher sun exposure, higher doses of Botox may be needed to achieve the same degree of forehead muscle paralysis, compared to less-sunny countries,” comments lead author Kim L. Borsky, MBBS, MD, MRCS, of the U.K.-based Stoke Mandeville Hospital. “Our results suggest that plastic surgeons may need to adjust their Botox dosing protocols to account for the effects of climate on the results of this cosmetic treatment.”

Could Sun Exposure Affect Responses to Cosmetic Botox?

Administration of “injectables” is the most common minimally invasive cosmetic procedure performed by plastic surgeons. According to ASPS statistics, injection of neuromodulators such as botulinum toxin type A—best known by the brand name Botox—was performed more than 8.7 million times in 2022. Botox blocks nerve signals to the injected muscles, causing reversible muscle paralysis. This allows softening and relaxation of lines and wrinkles of the overlying skin.

Plastic surgeons have noticed variations in the improvement achieved by Botox injections. While several factors are known to affect the response – including muscle mass, gender, age, and ethnicity—other unidentified factors may also play a role.

Could climate contribute to differences in the response to cosmetic Botox injections? Borsky and her colleagues compared outcomes of Botox treatment in two groups of patients: a “high-sun” group of 292 women in the Mediterranean island nation of Malta and a “low-sun” group of 231 women treated in London. Patients in Malta were treated during the summer months, while the UK patients were treated in the winter months.

Botox Treatments ‘May Need to Account for Climate’

The patients underwent Botox injections into the glabellar muscles of the lower forehead; all treatments were performed by experienced plastic surgeons following a standardized technique. At follow-up visits, patients received “top-up” doses as needed to achieve “full clinical paralysis.” The total Botox dose needed to achieve this result was compared between the high-sun and low-sun groups.

The results showed a higher average total Botox dose in the high-sun group: 29.2 versus 27.3 units. Patients in Malta also received a higher average top-up dose: 2.24 versus 1.98 units. The differences in Botox dose remained significant after adjustment for age and other factors.

Why would patients in sunny climates need more Botox? Noting that the glabellar muscles are the main muscle group involved in squinting, Borsky and colleagues speculate that the difference may reflect greater development and functional activation of these muscles. Other possibilities include the effects of higher temperatures or the direct effects of sunlight on the response to Botox.

The researchers note that the small difference in their study isn’t likely to have a large impact on treatment costs, but it may have implications for training and treatment. “Rigid protocols about doses and distributions may lead to undertreatment if applied in sunnier climates,” Borsky and her coauthors conclude. “Treatment protocols may need to account for the climate in which treatments are being undertaken to achieve more predictable results.”

Summary: Preoperative Botox injections serve as a reliable diagnostic tool to predict favorable outcomes in migraine surgery, with a positive predictive value of nearly 90%, suggesting their usefulness in identifying patients who will benefit from the procedure.

Key Takeaways

1. Preoperative Botox injections effectively predict the success of migraine surgery, with a positive predictive value of nearly 90%, aiding in identifying responsive patients.
2. Patients who exhibit positive responses to Botox injections show significantly better outcomes in migraine surgery, including greater reductions in intensity and frequency of migraine attacks.
3. While Botox injections serve as a valuable diagnostic tool, they also have limitations, with about half of patients with unsuccessful Botox injections still experiencing improvement after surgery, suggesting the need for additional tests to assess trigger point involvement.

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Preoperative Botox injections are a useful test for predicting how well patients with chronic migraine will respond to nerve decompression surgery, reports a study in the May issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

“Our study supports the value of preoperative Botox injections as a reliable diagnostic tool for identifying patients who will respond to migraine surgery, with a positive predictive value of nearly 90%,” comments ASPS Member Surgeon Jeffrey E. Janis, MD, of The Ohio State University Wexner Medical Center, Columbus.

Can Botox Injections Predict Successful Migraine Surgery?

Peripheral nerve decompression, or trigger point deactivation surgery, has become an established treatment for chronic migraine headaches and some neuralgias, like occipital neuralgia. Migraine surgery seeks to address nerve compression at trigger sites in the head and neck, which are thought to contribute to headaches.

Injections of botulinum toxin—best known by the brand name Botox—may be performed as a preoperative test to confirm trigger site involvement. If Botox injections prevent or reduce migraine attacks, it supports the involvement of that trigger site in the patient’s headaches. However, few studies have evaluated how well Botox injections predict the response to headache surgery.

Janis and colleagues reviewed their department’s experience in 40 patients undergoing headache surgery. All patients underwent targeted diagnostic Botox injections based on their headache characteristics and previously identified trigger sites. Responses to Botox testing were evaluated as a predictor of improvement after nerve decompression.

Three months after surgery, all patients had improvement on a standard migraine score (the Migraine Headache Index, or MHI), with reductions in a combination of duration, intensity, and/or frequency of migraine attacks. About half of patients (19 of 40) had a positive response to Botox injection, with at least a 50% reduction in MHI.

Positive Botox Tests Improve Migraine Surgery Outcomes

Patients with successful Botox injections had better outcomes on most measures of the response to headache surgery. Average improvement in MHI score was about 90% after positive responses to Botox testing, compared to 49% in those with negative responses.

Patients with positive responses to Botox had greater reductions in migraine intensity, about 57% versus 26%; and migraine frequency, 78% versus 47%. Migraine duration was also shorter in patients with successful Botox injections, although the difference was not statistically significant.

Overall, surgery was rated successful (at least a 50% reduction in MHI) in 17 of 19 patients with positive results on Botox injection, compared to 13 of 21 patients with negative Botox results. A successful Botox test had a positive predictive value of 89.5%. In other words, about 9 out of 10 patients with a successful diagnostic Botox injection had improvement after migraine surgery.

On the other hand, preoperative Botox injection had a negative predictive value of 38%—“which means that over half of the patients that had an unsuccessful Botox injection will still improve after surgery,” Janis and his colleagues explain. They note that patients with unsuccessful Botox injection may benefit from further tests to assess trigger point involvement. In a prior study, the researchers demonstrated the high predictive value of peripheral nerve blocks in mapping migraine trigger sites.

The authors point out some limitations of their study, which included a relatively small number of patients treated in a single plastic surgery department. Janis comments: “We recommend the routine use of diagnostic Botox injections as well as nerve blocks with the goal of confirming trigger sites and identifying patients who are more likely to benefit from migraine surgery.”

Fat-dissolving injections not approved by the FDA are being sold under various brand names, including Aqualyx, Lipodissolve, Lipo Lab, Kabelline, and others. These products claim to reduce fat deposits in areas such as the chin, back, thighs, upper arms, and stomach. They often contain ingredients like phosphatidylcholine (PPC) and sodium deoxycholate (DC), sometimes referred to as “PCDC injections.” The FDA has not evaluated the safety or effectiveness of these unapproved ingredients, the agency says.

Reports have surfaced of consumers experiencing adverse reactions after using unapproved fat-dissolving injections, including permanent scars, serious infections, skin deformities, cysts, and painful knots. Some individuals received these injections from improperly licensed personnel, while others purchased the unapproved drugs online and self-administered them, leading to severe health complications.

Improper injection techniques, coupled with the use of unapproved injections, increase the risk of scarring, skin infections, and other serious complications, the FDA says. Safe and effective use of these products depends on correct injection practices, including the right number and location of injections, proper needle placement, and appropriate administration techniques. Consumers are strongly discouraged from purchasing unapproved fat-dissolving ingredients or attempting self-injection.

The only FDA-approved fat-dissolving injectable drug is Kybella, containing deoxycholic acid. It is approved solely for reducing fat under the chin in adults. The FDA has evaluated Kybella for quality, safety, and effectiveness specifically for this area; it is not approved for use in any other body areas, the FDA says.

Consumers are urged to consult a healthcare professional to receive FDA-approved fat-dissolving injections and to avoid purchasing such products online for self-administration. Adverse reactions from fat-dissolving injections or any other medications can be reported via the FDA’s MedWatch program. 

Featured image: Multiple infected knots at the injection sites on the upper arm of a woman who received injections with Lipodissolve, a drug that is not FDA approved, and sought treatment at a dermatology clinic one week after the injections. (Kaur, H, C Reyes-Barron, WH Sipprell, A Cameron, T Louie, PR Tsai, and G Scott, 2022)