INTRODUCTION: In this study, we examined Radiesse (calcium hydroxylapatite; CaHA), Juvederm 24 (hyaluronic acid; HA-1A), Juvederm 24HV (HA-1B), and Perlane (HA-2) for patient satisfaction, likelihood to return, immediate efficacy, and duration of correction. OBJECTIVE: This multicenter, blinded, randomized study compares patient satisfaction variables, efficacy, and durability of CaHA gel and HA for correction of nasolabial folds (NLFs) through 12 months after 4-month touch-up. METHODOLOGY: A total of 205 randomized patients received either CaHA gel or HA for NLF treatment at initial visit and 4-month touch-up. Patients returned at 4, 8, and 12 months after the second injection for evaluation. Surveys measured patient satisfaction; effectiveness measures included the Global Aesthetic Improvement Scale (GAIS). RESULTS: More CaHA gel patients were satisfied or extremely satisfied than each HA tested. At 8 months, significantly more CaHA gel-treated NLFs were improved on the GAIS than any HA. The volumes of CaHA gel and three HA materials injected through 4 months were 2.2, 2.9, 4.8, and 2.9 mL, respectively (p<.005). No serious adverse events were observed. CONCLUSIONS: In this controlled study, CaHA gel ranked highest in patient satisfaction and likelihood to return. The material was more effective and longer lasting than each HA in maintaining NLF augmentation.
RCT Entities:
INTRODUCTION: In this study, we examined Radiesse (calcium hydroxylapatite; CaHA), Juvederm 24 (hyaluronic acid; HA-1A), Juvederm 24HV (HA-1B), and Perlane (HA-2) for patient satisfaction, likelihood to return, immediate efficacy, and duration of correction. OBJECTIVE: This multicenter, blinded, randomized study compares patient satisfaction variables, efficacy, and durability of CaHA gel and HA for correction of nasolabial folds (NLFs) through 12 months after 4-month touch-up. METHODOLOGY: A total of 205 randomized patients received either CaHA gel or HA for NLF treatment at initial visit and 4-month touch-up. Patients returned at 4, 8, and 12 months after the second injection for evaluation. Surveys measured patient satisfaction; effectiveness measures included the Global Aesthetic Improvement Scale (GAIS). RESULTS: More CaHA gel patients were satisfied or extremely satisfied than each HA tested. At 8 months, significantly more CaHA gel-treated NLFs were improved on the GAIS than any HA. The volumes of CaHA gel and three HA materials injected through 4 months were 2.2, 2.9, 4.8, and 2.9 mL, respectively (p<.005). No serious adverse events were observed. CONCLUSIONS: In this controlled study, CaHA gel ranked highest in patient satisfaction and likelihood to return. The material was more effective and longer lasting than each HA in maintaining NLF augmentation.