BACKGROUND:Hyaluronic acid-derived injectible fillers are ideal to reduce the appearance of nasolabial folding because their effect is relatively long-lasting, the material is malleable and easy to use, and there is a very low incidence of allergic reaction. OBJECTIVE: To compare the tolerability and efficacy of two commercially available hyaluronic acid-based fillers, Hylaform (INAMED Aesthetics, Inc., Santa Barbara, CA, USA) and Restylane (Medicis Pharmaceutical Corporation, Scottsdale, AZ, USA), in the treatment of nasolabial folds. METHODS:Eight healthy adult female subjects underwent filler injection therapy for tissue augmentation of their nasolabial folds. Each subject was randomized to receive Restylane 0.7 mL to either the right or the left nasolabial fold and Hylaform 1.0 mL to the contralateral side. High-quality digital photography was performed both at baseline and at 12 weeks post-treatment. These photographs were assessed by four blinded, independent dermatologist reviewers for improvement. Subjects completed questionnaires to document tolerability and satisfaction. RESULTS: All subjects found the procedure to be tolerable and completely pain free after the use of oral infraorbital regional anesthesia blocks. The average subject satisfaction score was 3.00 of 5 for Hylaform and 3.78 of 5 for Restylane. The blinded, independent reviewer panel attributed an average improvement score of 2.86 of 5 for Hylaform and 3.78 of 5 for Restylane. CONCLUSION: Both Hylaform and Restylane are effective fillers for tissue augmentation of the nasolabial folds. Restylane demonstrated higher efficacy and subject satisfaction than Hylaform. With regional nerve blocks prior to injection, both agents are completely painless.
RCT Entities:
BACKGROUND:Hyaluronic acid-derived injectible fillers are ideal to reduce the appearance of nasolabial folding because their effect is relatively long-lasting, the material is malleable and easy to use, and there is a very low incidence of allergic reaction. OBJECTIVE: To compare the tolerability and efficacy of two commercially available hyaluronic acid-based fillers, Hylaform (INAMED Aesthetics, Inc., Santa Barbara, CA, USA) and Restylane (Medicis Pharmaceutical Corporation, Scottsdale, AZ, USA), in the treatment of nasolabial folds. METHODS: Eight healthy adult female subjects underwent filler injection therapy for tissue augmentation of their nasolabial folds. Each subject was randomized to receive Restylane 0.7 mL to either the right or the left nasolabial fold and Hylaform 1.0 mL to the contralateral side. High-quality digital photography was performed both at baseline and at 12 weeks post-treatment. These photographs were assessed by four blinded, independent dermatologist reviewers for improvement. Subjects completed questionnaires to document tolerability and satisfaction. RESULTS: All subjects found the procedure to be tolerable and completely pain free after the use of oral infraorbital regional anesthesia blocks. The average subject satisfaction score was 3.00 of 5 for Hylaform and 3.78 of 5 for Restylane. The blinded, independent reviewer panel attributed an average improvement score of 2.86 of 5 for Hylaform and 3.78 of 5 for Restylane. CONCLUSION: Both Hylaform and Restylane are effective fillers for tissue augmentation of the nasolabial folds. Restylane demonstrated higher efficacy and subject satisfaction than Hylaform. With regional nerve blocks prior to injection, both agents are completely painless.
Authors: Daisy Kopera; Michael Palatin; Rolf Bartsch; Katrin Bartsch; Maria O'Rourke; Sonja Höller; Renate R Baumgartner; Martin Prinz Journal: Biomed Res Int Date: 2015-03-03 Impact factor: 3.411