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 > or = 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.