Radiesse

Radiesse 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.

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.

• Results:

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:

• Radiesse is contraindicated:

• Radiesse Warnings

• Radiesse Precautions

• Common Side Effects

• Rare Side Effects

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