Six-Month, Double-Blind, Randomized, Split-Face Study to Compare the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Mixed with Lidocaine and CaHA Alone for Correction of Nasolabial Fold Wrinkles

Grunebaum, Lisa D.; Elsaie, Mohamed L.; Kaufman, Joely

doi:10.1111/j.1524-4725.2010.01555.x

Cited by 22 publications

(21 citation statements)

References 15 publications

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“…The Food and Drug Administration has since approved the option of combining lidocaine with RDF. One of the articles in this supplement compares premixed lidocaine and RDF with RDF alone for treatment of nasolabial folds 2 …”

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confidence: 99%

“…One of the articles in this supplement compares premixed lidocaine and RDF with RDF alone for treatment of nasolabial folds. 2 Other physicians have described their experiences in pretreating with lidocaine followed by injection of RDF. [3][4][5] For this randomized and evaluator-blinded study, investigators addressed the safety and efficacy of RDF itself for rejuvenation of the aging hand, using only a small volume of lidocaine administered before injection.…”

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confidence: 99%

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Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

Busso¹,

Moers‐Carpi²,

Storck³

et al. 2010

Dermatologic Surgery

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OBJECTIVE To assess the safety and effectiveness of calcium hydroxylapatite (Radiesse Dermal Filler; RDF) for hand rejuvenation.METHODOLOGY One hundred and one randomized patients received RDF in the hands or no treatment (controls) for 3 months. Controls were crossed over at 3 months, and all patients were followed for 12 months. Assessments include the Busso Hand Volume Severity Scale (BHVSS), Global Aesthetic Improvement Scale-Revised (GAIS-R), patient satisfaction, physician satisfaction, hand function, and safety.RESULTS At 3 months and 6 months, 66% and 56% of hands, respectively, showed at least a 1-point improvement on the BHVSS. At the same time points, 89% and 75% of hands, respectively, were improved on the GAIS-R. In the controlled analysis, treated hands were statistically better than controls. At 3 and 6 months, 86% and 88% of physicians, respectively, and 78% and 76% of patients, respectively, were satisfied; 66% indicated likelihood to return for future RDF treatments. Treatment did not affect hand function. Adverse events were generally short in duration and without serious complications.CONCLUSIONS Hands treated with RDF showed statistically and clinically significant improvement, with high patient and physician satisfaction and no serious adverse events. BioForm Medical (San Mateo, CA) provided the Radiesse soft tissue filler, funding, supplies and equipment for photographic documentation for this study. Dr. Mariano Busso owns shares in BioForm Medical, Inc, is a member of the company's Medical Education Faculty, and has received compensation for presentations aboutRadiesse to the medical community. Dr. Marion Moers-Carpi owns no stock in BioForm but has received compensation for presentations about Radiesse to the medical community. The remaining physicians have nothing to disclose. David J. Howell, PhD, RRT (San Francisco, CA) provided assistance with editorial development of this manuscript.

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confidence: 99%

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confidence: 99%

Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

Busso¹,

Moers‐Carpi²,

Storck³

et al. 2010

Dermatologic Surgery

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“…Pain on administration of CaHA is significantly reduced by mixing CaHA with 0.2–0.4 mL of 2% lidocaine, administered with 1.3 mL syringes. Furthermore, the viscosity and extrusion force to inject the product is also significantly decreased with this dilution (20,21).…”

Section: Calcium Hydroxylapatitementioning

confidence: 92%

Complications of injectable fillers and neurotoxins

Cox¹,

Adigun

2011

Dermatologic Therapy

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All cosmetic injectable products are associated with the risk of both early and delayed complications. Early and expected side effects include swelling, bruising, and erythema at the injection. It is of utmost importance that patients are educated on the treatment they are consenting to receive and the potential risk of these therapies. Side effects of the various cosmetic injectable products, including both injectable neurotoxins and soft tissue fillers, are often technique associated, such as placing the filler too superficial or unintentional paralysis of facial muscles. Other complications, such as necrosis, intravascular injections, and infection may not be entirely technique-dependent, and must be managed swiftly and effectively. Finally, immunologic phenomena, such as delayed-type hypersensitivity reactions and foreign body granulomas, are complications that have no relationship to technique, and thus proper counseling and knowledge of management is required.

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“…A subsequent splitface study demonstrated comparable aesthetic correction at six months between CaHA and CaHA mixed with lidocaineaine. 14 The elasticity and pH of CaHA are not affected by the addition of lidocaine.…”

Section: Calcium Hydroxylapatite (Caha)mentioning

confidence: 98%

Nonsurgical Modalities to Treat the Aging Face

Fitzgerald¹,

Graivier²,

Kane³

et al. 2010

Aesthetic Surgery Journal

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Six-Month, Double-Blind, Randomized, Split-Face Study to Compare the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Mixed with Lidocaine and CaHA Alone for Correction of Nasolabial Fold Wrinkles

Abstract: BACKGROUND Safety, pain, duration of effect, and patient satisfaction are important concerns for physicians performing dermal filler injections.

Cited by 22 publications

References 15 publications

Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

Complications of injectable fillers and neurotoxins

Nonsurgical Modalities to Treat the Aging Face

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