Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane Perlane and Hylaform, in the treatment of nasolabial folds

BACKGROUND. Cross-linked hyaluronic acid gels may offer longer-lasting cosmetic correction and a lower risk of immunogenicity than other soft tissue augmentation agents. OBJECTIVE. To compare the efficacy and safety of a non-animal-stabilized hyaluronic acid gel (Restylane Perlane, Q-Med, Uppsala, Sweden) with that of a hylan B gel (Hylaform, Genzyme Corp., Cambridge, MA, USA), a cross-linked hyaluronic acid from chicken combs, for treatment of nasolabial folds. METHODS. One hundred fifty patients with moderate or severe nasolabial folds were randomized to contralateral treatment with Restylane Perlane and Hylaform. Efficacy was assessed using semi-objective outcome instruments at 3, 4.5, and 6 months after achievement of an "optimal cosmetic result." Patients subsequently underwent open-label bilateral retreatment with Restylane Perlane (if required) and were followed up for a further 6 months. RESULTS. The two products were equally effective in producing an optimal cosmetic result, although fewer treatment sessions were required with Restylane Perlane. At 6 months post-treatment, a higher proportion of patients showed a >= 1-grade improvement in Wrinkle Severity Rating Scale (WSRS) score with Restylane Perlane (75%) than with Hylaform (38%). Restylane Perlane was considered superior in 64% of patients, whereas Hylaform was superior in 8% of patients. Treatment-related adverse events tended to be more frequent with Restylane Perlane. Local injection-site reactions were generally transient and mild or moderate in intensity and were no more frequent after Restylane Perlane retreatment. CONCLUSIONS. Restylane Perlane provides a more durable esthetic improvement than Hylaform and offers acceptable tolerability.