Nasolabial Fold Correction Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Versus Restylane® for the Correction of Nasolabial Folds
A randomized, multicenter, double blind, split-face study in subjects seeking NLF correction. Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane in the NLF on the other side of the face. The side of the face for each product was randomly assigned. The investigator performing the evaluations and the subject were blinded to the treatment; injections of the study product were performed by an unblinded injecting investigator.
The study was a randomized, double-blind prospective, comparative study of the efficacy and safety of Revanesse Ultra versus the approved product Restylane in the cutaneous correction of NLFs. Randomization followed a 1:1 within-subject control model of augmentation correction of NLFs. Given that the implants have been shown to not migrate, the within-subject model was ideal and had already been shown in previous studies to detect differences. Subjects with signs of NLFs who met the entry criteria were enrolled. All subjects were followed for efficacy and safety for 6 months. Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their baseline WSRS scores had returned to baseline, or as needed to achieve optimal correction if their baseline WSRS scores had not returned to baseline and were followed for a total of 12 months. The study design was appropriate for the indication studied. ;
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