Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the publication of new research demonstrating that RADIESSE stimulates collagen production as well as other key components of the skin’s extracellular matrix (ECM) to support skin regeneration. The findings also show that RADIESSE improves signs of solar elastosis, a significant component of sun damage in skin.
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Published in the Journal of Cosmetic Dermatology, the six-month, placebo-controlled human biomarker study is one of the most comprehensive human-based evaluations of ECM regeneration in aesthetic medicine.
“While previous research has shown that biostimulation with RADIESSE has a positive impact on both collagen and elastin production, the latest evidence published today demonstrates it also supports a broader remodeling process – including notable improvements to sun damaged skin,” said Owen Sunga, M.D., Executive Vice President, Head of Global Medical Affairs.
The ECM is a complex network of structural proteins responsible for the skin’s mechanical support and hydration.1 Healthy skin function depends on the integrity of multiple ECM components.2 The study evaluated how undiluted and diluted formulations of RADIESSE – an injectable regenerative biostimulator – affects this ecosystem over six months, measuring improvements across several key proteins:
- Collagen, responsible for structure and firmness, increased up to 23 times versus saline placebo
- Elastin, which gives skin its elasticity, increased by 96% versus saline placebo
- Decorin and versican, key hydration and structure-supporting ECM components, increased by 82% and 129% respectively versus saline placebo
In addition to supporting the regeneration of key components of skin, these findings also highlight that RADIESSE plays a role in reversing ultrasonographic features of solar elastosis, a hallmark of sun-damaged skin that contributes to wrinkles, laxity and crepiness over time. At sites treated with RADIESSE, there were significant improvements in elastosis at both three and six months, providing further evidence of improvements throughout multiple tissue layers.
“Sun damage is one of the most common concerns we see in patients, and the damage itself extends far beyond what’s visible on the surface,” said Gabriela Casabona, M.D., study author and renowned dermatologist. “Finding that RADIESSE plays a role in addressing ultrasonographic features of solar elastosis adds an important dimension to how we think about this treatment.”
The publication of these findings marks a meaningful advance in the science of biostimulation and the standard by which skin health is evaluated in the field. Merz Aesthetics remains committed to generating evidence that helps clinicians and patients better understand what effective regeneration can look like, from the inside out.
What are RADIESSE® and RADIESSE® (+)?
RADIESSE® and RADIESSE® (+) are dermal fillers that are used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth).
RADIESSE® is also used for correcting volume loss in the back of the hands and, when diluted with saline to smooth away wrinkles such as those in the décolleté in patients 22 years of age and older. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.
RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION
Who should not use RADIESSE® or RADIESSE® (+)?
You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.
What is the most important information I should know about RADIESSE® and RADIESSE® (+)?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
As with all procedures that involve an injection through the skin, there is a risk of infection.
Do not use RADIESSE® or RADIESSE® (+) if you have a skin infection until it has healed.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes, or if you are pregnant or breastfeeding.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective beyond 3 years in the face, 1 year in the hand, and 84 weeks in the décolleté.
Injection of RADIESSE® (+) into the jawline may temporarily alter jaw function.
The safety of RADIESSE® in the décolleté in patients under 22 years of age has not been established.
The microspheres in RADIESSE® and RADIESSE® (+) can be seen in X-rays and CT scans. It is very important that you tell your health care provider that you have had RADIESSE® or RADIESSE® (+) dermal filler. A clinical study found no evidence of RADIESSE® injected in the décolleté being visible on mammograms or breast ultrasounds, but you should still inform your doctor and radiologist that you have received RADIESSE® in the treated area so they can interpret your imaging appropriately.
If you have a history of herpes, you may experience a herpes breakout after receiving RADIESSE® or RADIESSE® (+).
Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.
You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.
What should I tell my doctor before using RADIESSE® or RADIESSE® (+)?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site. Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history forming large, raised scars or if you have had any other skin treatments such as skin peels.
What are the most common adverse events with RADIESSE® or RADIESSE® (+)?
The most common adverse events seen in clinical studies of RADIESSE® used in the hands include bruising, redness, swelling, pain, itching, nodules or bumps/lumps, difficulty performing activities, loss of sensation and other local side effects. The most common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching, difficulty chewing, and other local side effects.
Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
These are not all of the possible side effects with RADIESSE® or RADIESSE® (+). Merz collects information about adverse events seen with RADIESSE® and RADIESSE® (+) outside of clinical studies. These events are included in the RADIESSE® and RADIESSE® (+) Patient Information Guide based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the Patient Information Guide available at www.radiesse.com for list of these events. Tell your health care provider about any side effects that bother you or do not go away.
Important: For full safety information, please visit www.Radiesse.com or call MyMerz Solutions at 1-844-469-6379
RADIESSE® and RADIESSE® (+) are available by prescription only.
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.
References
- Pfisterer K, et al. Front Cell Dev Biol. 2021 Jul 6;9:682414.
- Jiang F, et al. Sci Rep 15. 28598 (2025).
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