Efficacy and Safety of RADIESSE^® in Enhancing Décolleté: Insights from Recent Studies

Welcome to this edition of our newsletter, focused on RADIESSE^® Injectable Implant, we are happy to announce the new indication for RADIESSE^® as a key tool for treating moderate to severe décolleté wrinkles.

Comprised of Calcium hydroxylapatite (CaHA) in a gel carrier, RADIESSE^® offers a non-permanent solution for décolleté rejuvenation.

This issue is designed to support healthcare professionals by providing knowledge on the techniques, safety protocols, and clinical evidence supporting the use of RADIESSE^® in aesthetic practices.

We also review the latest clinical data, affirming the long- term effectiveness of the implant in improving the appearance of the décolleté area for up to 12 months.

Given its minimally invasive nature and the ability to customize treatments across multiple sessions, hyperdiluted Radiesse is a promising addition to aesthetic treatment strategies, offering significant patient satisfaction.

Disclaimer: RADIESSE^® Injectable Implant is officially indicated for the treatment of nasolabial folds, cheek augmentation, hand augmentation to correct volume loss, the restoration and/or correction of the signs of facial fat loss in people with HIV, and diluted 1:2 with 0.9% sterile saline for the treatment of moderate to severe décolleté wrinkles. Merz is not responsible for any off-label use of its products.

The appearance of the décolletage, or upper chest area, significantly impacts many women’s self-esteem and confidence. As this area is frequently exposed in various types of clothing, such as dresses and tops, its condition can influence a woman’s overall sense of self.

Signs of aging, such as wrinkles and sagging skin, can lead to self-consciousness and a desire for effective treatments.

Utilizing RADIESSE^® Injectable Implant to treat moderate to severe décolleté wrinkles offers a clinically proven solution to rejuvenate and restore the youthful appearance of the décolletage, thereby enhancing women’s self- assurance and sense of beauty.

Recent studies highlight the efficacy of diluted and hyperdiluted Radiesse^®. A multicenter randomized clinical trial involving 117 women compared the effects of three versus two injection cycles of hyperdiluted CaHA (1:2 ratio) over 16 weeks (1).

Results showed significant improvement in décolleté wrinkles at 32- and 52-weeks post- treatment, with 73.5% of participants showing a

≥1 point improvement on the Merz Aesthetic Scale (MAS) Décolleté Wrinkles-At Rest scale. (Figure 1).

Supporting studies by Yutskovskaya et al. (4) and Fabi et al. (5) also demonstrate the biostimulatory effects of hyperdiluted CaHA on skin quality, including improved collagen production and skin elasticity.

These findings underscore the potential of CaHA in both immediate cosmetic enhancements and long-term dermal remodeling.

Global and regional expert panels have developed guidelines to optimize the use of diluted and hyperdiluted CaHA. These recommendations emphasize the importance of technique and product consistency to achieve the best outcomes. Key guidelines include:

Using only sterile 0.9% NaCl for dilution.
Ensuring even distribution of CaHA by adopting a linear threading retrograde technique.
Vigorous post-treatment massage to promote product spread and effectiveness.

The Brazilian panel, in particular, advises a dilution ratio of 1:2 to 1:4 based on skin thickness, advocating for a personalized approach to treatment (6). Similarly, the global panel suggests follow-up assessments at 6 to 9 months to evaluate the need for additional treatments (7).

Proper technique is crucial for maximizing the benefits of diluted and hyperdiluted CaHA treatments. Recommendations include (7,8):

A minimum of 20 mixing strokes to ensure homogeneity of the dilution.
Use of a linear threading technique with either a needle or cannula for deep dermal or subdermal injections.
Immediate use of the mixture post- preparation to maintain sterility and effectiveness.

Advanced techniques from Siebenga and van Loghem include using vectorized figures to standardize injection patterns for comprehensive coverage of the décolletage area, highlighting the importance of precision in aesthetic procedures (9).

Safety and Patient Satisfaction

While the aesthetic outcomes are promising, patient safety and satisfaction remain paramount. The reported side effects are generally mild and transient, such as injection site reactions and minor bruising, which typically resolve within a week (5).

Patient satisfaction rates are high, reflecting the effectiveness and tolerability of the treatments.

Conclusion

For any queries, comments or request for support, you may contact the medical team at Medinfo.me@merz.com

For more details, please consult the leaflet insert