Radiesse

Generic Name: Calcium Hydroxylapatite
Company: Merz Aesthetics, Inc.
Treatment for: Correction of moderate to severe facial wrinkles/folds; restoration and/or correction of signs of facial fat loss in patients with HIV

What is Radiesse?

Radiesse (calcium hydroxylapatite) is a FDA-approved subdermal implant (injected below the surface of the skin) indicated for:

  • the correction of moderate to severe facial wrinkles and folds (nasolabial folds)
  • for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in patients with HIV.

Radiesse is composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. Radiesse is injected subdermally by a healthcare provider. The number of treatments needed are determined by a healthcare professional based upon the individual needs of the patient.

According to the manufacturer, Radiesse is an injectable filler that works by immediately restoring facial volume to smooth out the signs of aging. Once injected, it stimulates the production of natural collagen for results that may last a year or more. Visible results can be seen immediately.

Radiesse is available in a 1.5, 1.3, 0.8 and 0.3 cc syringe size. Radiesse is injected using a 25 to 27 gauge needle, and is FDA approved to mix with 2% lidocaine (an anesthetic) to control discomfort during injection for nasolabial folds, if needed. The safety and effectiveness of mixing 2% lidocaine and Radiesse injectable implant for use in patients with facial fat loss (lipoatrophy) in HIV has not been studied. Allergy or skin testing is not required prior to Radiesse treatment. For most patients, little to no recovery time is needed after Radiesse injections.

Radiesse Clinical Trials

Nasolabial Folds

In a multi-center, blinded, prospective, randomized clinical trial evaluating Radiesse treatment for the correction of moderate to severe facial wrinkles and folds, 117 patients were randomized to receive Radiesse in one fold and a commercially available collagen implant in the contra-lateral fold as a control. Based on investigator assessment, patients were eligible to receive up to three injections during the treatment phase (at weeks 0, 2 and 4). Safety evaluations were conducted at 1, 3, and 6 months. Efficacy was determined by using a validated 6-point wrinkle severity scale (Lemperle Rating Scale).

The primary efficacy endpoint was met at 3 months after the final treatment. Radiesse was shown to be non-inferior to the control for the correction of nasolabial folds.

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  • Results:
    • At 3 months, 84.6% of the Radiesse-treated nasolabial folds scored at least 1 point higher than the control.
    • At 6 months, secondary endpoints were also met, with 78.6% of Radiesse-treated nasolabial folds scoring at least one point higher on the Lemperle Rating Scale than the control folds.

HIV-associated Facial Lipoatrophy

In a multi-center, open-label, prospective study evaluating Radiesse treatment for restoration of facial fat loss (lipoatrophy) in patients with HIV, 100 patients received an initial Radiesse injection and then an additional injection at one month as needed. At 6 months, all patients were assessed for the need for an additional touch-up injection, for a total of 3 possible injections. Efficacy was assessed at 3 and 6 months using the Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction. Safety was assessed through 12 months.

Seventy-eight percent of patients received a total of three treatments with a mean initial treatment volume of 4.8 mL. Eight-five percent of patients received a treatment at one month with a volume of 1.8 mL, and the third injection volume of 2.4 mL at 6 months. No patient received more than three treatments.

  • Results:
    • At the 3 month evaluation, GAIS ratings were scored as “very much improved” or “much improved” in 98% of patients
    • At 6 months, GAIS rating were scored as “very much improved” or “much improved” in 93% of patients.
    • Cheek skin thickness measurement changes from baseline were all statistically significant at 3 and 6 months, and patient satisfaction scores exceeded 90% at both 3 and 6 months.

Radiesse Safety Information

  • Radiesse is contraindicated:
    • for patients with a history of anaphylaxis, or a history or presence of multiple severe allergies
    • in patients with known hypersensitivity to any of the components
    • in patients with bleeding disorders
  • Radiesse Warnings
    • Defer treatment in patients with active skin inflammation or infection near treatment area.
    • Avoid injection into blood vessels.
    • Do not overfill a contour deficiency as depression should improve within several weeks.
    • The safety and efficacy of Radiesse for lip augmentation has not been established. Lip nodules associated with the use of Radiesse in the lip area have been reported.
  • Radiesse Precautions
    • Radiopaque particles of calcium hydroxylapatite are visible on CT scans and radiography. Patients should be informed of the radiopaque nature of Radiesse and told to inform their healthcare providers. Radiesse has not been shown to mask abnormal tissue or be misinterpreted as a tumor on CT scans.
    • Healthcare providers should familiarize themselves completely with the Radiesse product prior to administration.
    • A Radiesse syringe is for single patient use.
    • The safety of Radiesse in patients with increased susceptibility to keloid formation and hypertrophic scarring is not known.
    • Standard infection control, universal precautions, and aseptic technique should be followed.
    • Treatment syringes may be biohazards and should be disposed of accordingly.
    • Radiesse safety in pregnancy, breastfeeding or patients under 18 years is not known.
    • Patients using anticoagulants, including aspirin, may experience increased bleeding or bruising at the injection site. Patients should inform their healthcare provider of all medications they use, including over-the-counter, dietary or herbal supplements.
    • Patients should minimize exposure of treated area to extensive sun or heat for 24 hours after treatment or until initial swelling and redness is resolved.
    • Safety and effectiveness of Radiesse in the periorbital (eye) area has not been established.
    • Interaction studies of Radiesse with other substances, drugs or implants have not been conducted.

Radiesse Side Effects

  • Common Side Effects
    • swelling
    • bruising
    • redness
    • pain
    • itching
  • Rare Side Effects
    • prolonged swelling
    • firmness in the injection area
    • infection

Most side effects of treatment resolve in 7-14 days. If side effects persist, contact your healthcare provider immediately.

For complete administration, dosing and safety information refer to the manufacturers package labeling for Radiesse.1, 2

References:

  1. Radiesse Injectable Implant. [package insert] Franksville, WI. Merz Aesthetics, Inc. 2011 October. http://www.radiesse.com/en-US/downloads/RADIESSE_Wrinkle_Filler_Instructions_for_Use.pdf Accessed February 11, 2012.
  2. Drugs.com. Calcium hydroxylapatite. http://www.drugs.com/ppa/calcium-hydroxylapatite.html Accessed February 11, 2012.

Last Updated: 2/26/2012

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