Radiesse holds FDA approvals for several areas of the body, but not for every area it is used on. Two of the three sites people search for together — the jawline and the backs of the hands — have their own approval and their own trial. The neck has neither. This page reads the two trials from FDA's published summaries and sets out what has been published about the neck, as of 20 October 2026. It makes no recommendation; whether a treatment suits someone is a question for a licensed clinician.
Approved and not approved, by site
| Site | Status in FDA's approval database | Record |
|---|---|---|
| Backs of the hands | approved, 4 June 2015 | P050052/S049 |
| Jawline | approved for Radiesse (+), deep injection, adults over 21, 1 September 2021 | P050052/S129 |
| Neck | no indication | — |
| Décolleté (upper chest) | approved diluted 1:2 with saline, 31 March 2026 | P050052/S162 |
The décolleté trial and the dilution question are covered on our hyperdilute Radiesse page; the full approval history and what the product is made of are on the Radiesse page.
The jawline trial
FDA's Summary of Safety and Effectiveness Data for the 2021 approval describes a 60-week, multicentre, randomized, controlled study. Between August 2018 and January 2020, 180 adults with moderate to severe loss of jawline contour were randomized two to one: 123 to Radiesse (+) in both sides of the jaw, 57 to no treatment until the 12-week assessment, after which they could be treated. A touch-up was allowed four weeks after the first session. Evaluators who scored the jaws on the Merz Jawline Assessment Scale did not know which group a person was in.
| Measure | Treatment | Untreated control |
|---|---|---|
| Responders at week 12 (primary endpoint) | 75.6% (93/123) | 8.8% (5/57) |
| Difference (95% CI) | 66.8% (53.7% to 75.2%) | |
| Investigator rated improved, week 12 | 99.1% (115/116) | — |
| Patient rated improved, week 12 | 94.0% (109/116) | — |
| Still responders at week 48, among week-12 responders | 67.3% (76/113) | — |
The volumes are worth knowing because they decide cost: the median first injection was 1.80 mL per side, touch-ups about 1.1 to 1.25 mL per side, and optional retreatments about 1.4 to 1.5 mL per side. Patients also rated how old they looked on a visual scale and reported looking 2.9 years younger on average at week 12; that is a self-rating, not a measured outcome.
Side effects. Of 175 people treated, 42.9% reported an adverse event of any kind; 26.3% had one the investigator linked to the product or the injection. The commonest events were injection-site mass (10.9%), bruising (6.9%) and pain (6.9%). Rates of related events were similar across skin types, ages and ethnic groups in the pre-specified subgroup analysis. The label's general warning on injection into a blood vessel applies here as everywhere; it is summarised in Radiesse side effects.
The hand trial
The 2015 approval rested on a randomized, cross-over study of hand augmentation followed for 12 months. 118 people enrolled and four withdrew; 85 were randomized to immediate treatment and 29 to delayed treatment, which served as the control. Masked evaluators scored each hand on the Merz Hand Grading Scale.
| Measure | Result |
|---|---|
| Improved ≥1 point at 3 months (primary endpoint) | 75.3% treated (64/85) vs 3.4% control (1/29) |
| Still improved ≥1 point at 12 months | 68.2% |
| Subjects rating their hands improved at 12 months | 86.4% |
| Mean first-session volume, both hands | 5.18 cc |
| Mean retreatment volume | 3.25 cc |
Side effects. The hand summary is blunter than the jawline one. Every subject reported at least one adverse event — swelling, pain, redness, bruising, itching, difficulty with everyday tasks, loss of sensation, lumps and haematoma among them. 24 of 113 (21%) reported an event described as severe; 29% had swelling lasting more than two weeks; events lasted from 1 to 312 days; and 58% had recurring events. More events were reported at higher volumes. FDA's summary records no serious device-related event, and all events resolved, some with treatment. The backs of the hands carry little fat over tendons and veins, which is one reason the trial asked about difficulty using the hands at all.
For comparison, poly-L-lactic acid has no hand indication; our page on Sculptra for the neck and hands sets out what has been published for it on both sites.
The neck: off-label, and a thin record
A PubMed search pairing calcium hydroxylapatite or Radiesse with the neck returned 32 records on 20 October 2026. Read one by one, several are not about cosmetic neck treatment at all: calcium hydroxylapatite is also injected into the vocal cords to treat a weak voice and into the urethra for incontinence, and those papers — a neck abscess after vocal-fold injection, airway swelling after injection laryngoplasty — appear in the same search. What remains for the cosmetic neck is:
- Consensus and guidance papers on diluted and hyperdiluted use (2018 and 2019 global consensus documents; a 2022 practical-guidance paper), which describe technique rather than measure outcomes.
- Small series. A 2021 Italian study treated 20 people with neck laxity using filler diluted 1:2 and graded photographs at three months on a scale its authors had newly developed; it reported improvement and no major adverse events. Other reports are case series of a few patients.
- One study tagged as randomized: a 20-person split-face study (2020) combining diluted calcium hydroxylapatite with microfocused ultrasound across the lower face, neck and décolleté. Because the two treatments were given together, it cannot say what the filler alone did.
- Complications specific to the neck. A 2025 case report describes a 72-year-old woman who developed multiple firm nodules in the neck after a third session of hyperdilute filler; they resolved after five sessions of saline injection and cannula disruption. The authors note nodules are the commonest adverse event of the diluted product, particularly in moving, thin-skinned areas such as the neck.
No trial has compared neck treatment with no treatment, and no neck indication has been filed with FDA, as far as the approval database shows. The registry lists small investigator studies combining Radiesse with other treatments on the lower face and neck, none with posted results.
What is and is not established
Established: Radiesse has controlled-trial evidence and an FDA indication for the backs of the hands (2015) and, as Radiesse (+), for the jawline (2021); in both trials about three-quarters of treated people met the response definition against under one in ten controls, and about two-thirds still did at 48 weeks (jaw) or 12 months (hands). Side effects in the hand trial were universal and sometimes long-lasting.
Not established: any controlled evidence for neck treatment on its own; how Radiesse compares with hyaluronic-acid fillers or fat on the jaw or hands in an approval-grade trial; and how long results last beyond about a year. Costs for each site are discussed, with the limits of the published figures, on our Radiesse cost page.
Sources
- US FDA premarket approval database (openFDA), PMA P050052 supplements S049, S129 and S162, read 2026-10-20.
- US FDA. Summary of Safety and Effectiveness Data, P050052/S129 (Radiesse (+), jawline) and P050052/S049 (Radiesse, hands). accessdata.fda.gov, read 2026-10-20.
- ClinicalTrials.gov NCT03583359 (jawline pivotal, Merz North America, 180 enrolled, results posted), read 2026-10-20.
- Guida S, Longhitano S, Spadafora M, et al. Hyperdiluted calcium hydroxylapatite for the treatment of skin laxity of the neck. Dermatol Ther 2021;34(5):e15090. PMID 34363289.
- Yutskovskaya YA, Sergeeva AD, Kogan EA. Combination of calcium hydroxylapatite diluted with normal saline and microfocused ultrasound with visualization for skin tightening. J Drugs Dermatol 2020;19(4):405-411. PMID 32272518.
- Kang BY, Fabi SG, Hoss E. Prevention of calcium hydroxyapatite nodules in the neck with use of botulinum toxin: a case report and review. J Cosmet Dermatol 2025;24(8):e70385. PMID 40781936.
- Goldie K, Peeters W, Alghoul M, et al. Global consensus guidelines for the injection of diluted and hyperdiluted calcium hydroxylapatite for skin tightening. Dermatol Surg 2018;44 Suppl 1:S32-S41. PMID 30358631.
- PubMed search
(calcium hydroxylapatite[tiab] OR radiesse[tiab]) AND neck[tiab], 32 records, each title read; randomized-trial filter 1 record; run 2026-10-20.