In the EU, Merz Aesthetics announced today the approval for Radiesse® to treat the décolleté area. Radiesse is a regenerative biostimulator1 capable of regenerating multiple components of the skin tissue, resulting in healthier-looking skin,1,4,5 and is now approved for use in the décolletage, adding to the product’s versatility.
This new regulatory milestone directly answers patient demand, given there is a significant shift toward regenerative biostimulation as a preferred method of aesthetic treatment for patients.3 Google Trends Data further support this, showcasing a continual surge in searches for ‘collagen’ between 2016-2022, confirming a shift in aesthetic preferences for patients.3
“Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “Radiesse presents a unique solution to improving décolleté wrinkles and provides our customers and their patients a nonsurgical, effective option to address aging décolleté skin.”
Recent data from the International Society of Aesthetic Plastic Surgery reveal a 171.8% increase in worldwide nonsurgical procedures and minimally invasive treatments between 2018 and 2022 involving calcium hydroxylapatite, a primary ingredient in Radiesse, further showcasing the patient need.2
This large, multicenter clinical trial3,5,6 supported the décolleté approval and provided substantial evidence of Radiesse’s effectiveness, demonstrating a significant improvement in the appearance of décolleté wrinkles.3 Results from the clinical trial found that:
- Up to 73.5% of patients experienced improved décolleté wrinkles 16 weeks after their last treatment.3,ii
- Furthermore, 76.1% of patients demonstrated an enhancement in skin quality over the same period.3,iii
- Notably, physicians reported a high level of satisfaction among 77% of patients 16 weeks after their last treatment.3
“We know that patients are looking for treatment options that are minimally invasive; this approval not only expands the scope of Radiesse but also showcases a new era of aesthetic procedures, empowering patients to feel their best. Our findings speak for themselves and demonstrate the possibility of what this new indication could achieve for patients who are looking to improve the overall appearance of décolleté wrinkles,” said Dr. Tatjana Pavicic, who was part of the clinical study conducted by Merz Aesthetics.
This year, Radiesse celebrates its 20th anniversary, having sold more than 15 million syringes globally since 2005.3 Merz Aesthetics demonstrates a longstanding legacy and commitment to scientific innovation in the aesthetics field.3
After two decades on the market, the new décolleté indication allows practitioners more versatility to expand the treatment spectrum from the face to more corporeal treatments. Additionally, with its increased product adaptability, also in diluted form, it allows for personalized treatment to address patient needs.
“It’s patients who drive the need for the aesthetics market to adapt their offering,” said Gonzalo Mibelli, EMEA President, Merz Aesthetics. “We know that the current evolution in patient demand for products like Radiesse is set to grow. We predict an increase in year-on-year growth between 2023 and 2026 within the regenerative biostimulation category,3 and this is an area we want to own for our patients.”
Mibelli continued, “Our data showcases Radiesse’s effectiveness in reducing décolleté wrinkles. This approval also reflects a broader shift toward minimally invasive procedures driven by patients’ evolving preferences for enhancing their body’s anti-aging processes for aesthetic improvements.”
Even in the current landscape, findings from Medical Insight’s 2024 Global Aesthetic Market Study suggest that Radiesse has emerged as a category leader.7 This success is backed by over two decades of scientific data and clinical experience by Merz Aesthetics,4,8 with 250 publications3 and availability in over 85 countries.3
He continued, “The approval of the Radiesse décolleté indication is an exciting time for Merz Aesthetics. We can see that while there is a steady rise in the number of patients seeking to smooth wrinkles in the décolleté area, patients equally want more healthy-looking results and improved skin quality. This is something that Merz Aesthetics can support them with.”
Pivotal clinical study summary3 for Radiesse:
This EU approval stems from positive pivotal study results demonstrating the effectiveness and safety of Radiesse (Radiesse Dilute; 1:2 Radiesse: saline) for the treatment of moderate and severe décolleté wrinkles.
The Radiesse décolleté indication is based on a pivotal, prospective, randomized, multicenter, parallel-group, evaluator-blind study evaluating the safety and effectiveness of Radiesse in 117 subjects aged 18 to 65 years old, who presented with moderate to severe wrinkles in the décolleté. The study duration was 52 weeks. The primary endpoint was defined as a subject with ≥ 1-point improvement on the Merz Aesthetic Scale (MAS)1 Décolleté Wrinkles-At Rest compared to baseline.
Radiesse proved a clinically and statistically significant improvement in décolleté wrinkles and overall satisfaction, with 73.5% of the treated subjects achieving at least a 1-point improvement on the MAS Décolleté Wrinkles-At Rest scale at Week 16 after the last treatment. This positive finding was confirmed by the secondary effectiveness endpoints including further investigator-and patient-reported outcomes (MAS Décolleté Wrinkles-Dynamic scale, treatment satisfaction and Global Aesthetic Improvement of décolleté wrinkles). No treatment-related serious adverse events (AEs) occurred. The most common treatment-related AEs were injection-site reactions (bruising, erythema, swelling, pain, nodule) and were mild, transient (duration of less than 14 days) and resolved without sequelae.
Patients reported a high level of satisfaction (70%) and in a studied subset of subjects, 76.1% demonstrated an improvement in skin quality 16 weeks after their last treatment.
Indications and approvals of Radiesse vary by region.
About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
© 2024 Merz North America, Inc. All rights reserved. Merz and Merz Aesthetics are trademarks of and/or registered trademarks of Merz Pharma GmbH & Co. KGaA in the U.S. and/or certain other countries. Radiesse® is a trademark and/or registered trademark of Merz North America, Inc. in the U.S. and/or certain other countries.
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1. Kim, J. Clin Cosmet Investig Dermatol. 2019;12:771–784
2. International Society of Aesthetic Plastic Surgery, ISAPS international survey on aesthetic/cosmetic procedures, 2022
3. Merz Aesthetics®. Data on File. 2023
4. González, N, Goldberg, DJ. Dermatol Surg. 2019;45(4):547–551.
5. Yutskovskaya YA, Kogan EA. J Drugs Dematol. 2017;16(1):68–74.
6. Fabi, SG, et al. J Drugs Dermatol. 2021;20(5):534–537
7. Medical Insight, Inc, The Global Aesthetic Market Study. 2024
8. Fisher, GJ, et al. Arch Dermatol. 2008;144(5):666–672.
9. Landau M, et al. Dermatol Surg. 2016;42(7):842-52.
i “Healthy-looking skin” is defined by the regeneration of Collagen I and III, elastin, proteoglycans, and angiogenesis.
ii Improved at-rest appearance defined as a ≥1-point improvement on the Merz Aesthetics Scales Décolleté Wrinkles-At Rest assessed by the blinded live rater, analysed using a modified full analysis set with missing data replaced by a multiple imputation approach. 83% of patients showed improvement in the appearance of at-rest décolleté wrinkles following two treatments. In the primary endpoint of the study, 73.5% of patients pooled across treatment groups showed an improvement in the at-rest appearance of décolleté wrinkles 16 weeks after their last treatment.
iii Level of improvement in skin quality assessed according to iGAIS — Investigator Global Aesthetics Improvement Scale.