Diluted Calcium Hydroxylapatite Carboxymethylcellulose (Radiesse) for Décolleté Wrinkles: Safety and Effectiveness in Adult Females.

BACKGROUND

The décolleté is susceptible to intrinsic aging, photoaging, and mechanical stress (breast movement and weight), resulting in progressive thinning, laxity, and wrinkle formation. Although injectable fillers are increasingly used to improve décolleté appearance, controlled clinical data evaluating effectiveness and effects on breast imaging are limited.

OBJECTIVES

To evaluate the safety and effectiveness of diluted calcium hydroxylapatite carboxymethylcellulose (CaHA-CMC; Radiesse®), prepared at a 1:2 ratio with sterile saline, for treating moderate-to-severe décolleté wrinkles.

METHODS

Eligible females were randomized to immediate or delayed treatment. Patients assigned to immediate treatment received up to three diluted Radiesse sessions, with optional retreatment. Patients assigned to delayed treatment remained untreated through Week 24 (primary endpoint) and subsequently received the same treatment regimen without retreatment. Effectiveness was assessed by blinded evaluators using the Merz Assessment Scale (MAS) Décolleté Wrinkles - At Rest. Safety evaluations included adverse events, patient-reported treatment responses, and retrospective review of post-treatment radiographic breast imaging.

RESULTS

The Week 24 estimated responder rate (≥1-point improvement on the MAS Décolleté Wrinkles - At Rest) was 71.2% [95% CI: 61.4%, 79.4%] among treated patients compared with 6.3% [95% CI: 1.5%, 22.9%] among untreated controls, demonstrating a statistically significant between-group difference. Treatment was well tolerated, with predominantly transient, mild-to-moderate injection-site reactions. No interference attributable to diluted Radiesse was observed on post-treatment breast imaging.

CONCLUSIONS

Diluted Radiesse provided clinically meaningful improvement in décolleté wrinkles with a favorable safety profile and no observed impact on breast imaging, supporting its use as a nonpermanent injectable option for décolleté rejuvenation.