Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results.

BACKGROUND: Calcium hydroxylapatite (CaHA, Radiesse) is approved by the Food and Drug Administration for treatment of moderate to severe wrinkles and folds, including nasolabial folds (NLF). A pivotal NLF split-face study previously compared the performance of Radiesse to human-based collagen at six months and safety of Radiesse through one year. OBJECTIVE: The authors assess the long-term safety and effectiveness of Radiesse for the treatment of NLF. Postapproval long-term results now extend to more than three years and are presented here. METHODS: This study reports an extension phase of a previously reported one-year premarket study of 117 patients comparing Radiesse to collagen. During the initial study, patients were treated to optimal correction and then followed for 12 months; they were offered retreatment with Radiesse between six and 12 months in both folds to balance asymmetry. Of the 117 original split-face study subjects with moderate to severe NLF, 102 were enrolled in this extended follow-up. During this extension study, treating physicians used the Global Aesthetic Improvement Scale (GAIS) and clinical examination to evaluate subjects at intervals up to 39 months after the last injection of Radiesse. RESULTS: Forty percent of the folds evaluated at least 30 months after the last Radiesse treatment were graded as "improved" or better on the GAIS. Expectedly, the reported improvement was substantially less at this later time point than had been seen at earlier points in the premarket study, indicating some moderate, sustained improvement in some patients. There were no long-term or delayed-onset adverse events in these 102 patients followed for three years, including no reports of nodules, granulomata, or infections, such as have been reported with certain other dermal fillers. CONCLUSIONS: These results demonstrate the long-term safety and effectiveness of Radiesse. Three years after Radiesse injection, no delayed-onset or long-term adverse events were reported. In addition, many patients showed some long-term cosmetic improvement. The durability and safety of Radiesse compare favorably with other injectable fillers.

A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds.

BACKGROUND: Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler. OBJECTIVE: The objective was to compare the efficacy and safety of CaHA microspheres versus human-based collagen for the correction of nasolabial folds. MATERIALS AND METHODS: Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits. RESULTS: Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months (p<.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen (p<.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days. CONCLUSION: This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product.

Full-face laser resurfacing using a supplemented topical anesthesia protocol.

BACKGROUND: Laser resurfacing has become a popular modality for the treatment of photodamaged skin, rhytids, and acne scarring. In many cases, this procedure is performed under general anesthesia or intravenous sedation in conjunction with nerve blocks and local infiltration. OBJECTIVE: To evaluate the safety and efficacy of facial carbon dioxide laser resurfacing using a supplemented topical anesthesia protocol. DESIGN: Nonrandomized case series of patients observed for 1 year. SETTING: Outpatient surgery center. PATIENTS: Two hundred consecutive patients undergoing treatment for facial rhytids or acne scarring. Intervention Full-face carbon dioxide laser resurfacing procedures were performed using a supplemented topical anesthesia protocol. Pretreatment medications included diazepam, oral analgesics, and intramuscular ketorolac tromethamine. MAIN OUTCOME MEASURES: Tolerability of procedure, healing times, and adverse effects. RESULTS: Topical anesthesia provided effective and sufficient anesthesia in most cases. Only 10 of 200 patients required additional anesthesia (regional nerve blocks and/or local infiltration). Substantial improvement of rhytids, photodamage, and acne scarring was observed. Posttreatment hypopigmentation was seen in 1 patient. Scarring was not observed. Conclusion A supplemented topical anesthesia protocol for full-face laser resurfacing is a safe and effective alternative to traditional anesthesia strategies.

Safe and effective carbon dioxide laser skin resurfacing of the neck.

CO2 laser skin resurfacing remains the gold standard for treatment of photoaged facial skin. It can be used onto the neck to further blend in the treated area with non-treated, adjacent photodamaged skin as well as improve the superficial textural quality of the neck skin. This article provides an overview of laser skin resurfacing of the neck, including pre-operative evaluation, patient education and selection, laser settings and technique used, post-operative care, and identification and treatment of possible complications.

Sebaceous hyperplasia treated with a 1450-nm diode laser.

BACKGROUND: Sebaceous hyperplasia is a benign proliferation of the sebaceous gland. Previous treatment options have included isotretinoin, destructive modalities, and pulsed-dye laser. OBJECTIVE: To evaluate the efficacy of a 1450-nm diode laser for the treatment of sebaceous hyperplasia. METHODS: Ten patients with sebaceous hyperplasia were treated one to five times with a 1450-nm diode laser. Fluences of 16 to 17 J/cm2 were used, with cooling durations of 40 to 50 ms. Patients and physicians evaluated treated lesions for improvement. Measured areas of treated lesions were also recorded. RESULTS: In most cases, patients and physicians rated improvement as "very good" or better. After two to three treatments, 84% of lesions shrunk greater than 50%, and 70% shrunk greater than 75%. Adverse effects were unusual; one atrophic scar and one case of transient hyperpigmentation were observed. CONCLUSION: The 1450-nm diode laser is effective and safe for the treatment of sebaceous hyperplasia.