Rhytids Clinical Trial
Official title:
A Randomized, Evaluator-Blind, Multi-Center, Comparison of the Efficacy and Persistence of Correction of Nasolabial Folds With Restylane® Using Two Different Re-Treatment Schedules
A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.
The study will employ a randomized, evaluator-blind design. One of the nasolabial folds will
be randomly assigned to be corrected with Restylane and then re-treated at 4 ½ months. The
opposite side will be treated with Restylane and not re-treated until 9 months. Both
nasolabial folds will be re-treated at 18 months. Each subject will serve as their own
control, allowing comparison of the outcome between the contralateral sides.
This is a multi-center U.S. trial with a planned enrollment of 75 subjects at three centers.
The goal of the study is to enroll and complete follow-up for 60 evaluable subjects. In order
to compensate for early discontinuations, a total of at least 75 subjects will be recruited
and treated.
After giving written informed consent, potential study participants will undergo a screening
evaluation and initial treatment (Visit 1). The two nasolabial folds will be randomized for
treatment so that one side will be designated for re-treatment with Restylane at 4 ½ months;
the other at 9 months. At month 18 (Visit 7) both nasolabial folds will be re-treated.
Follow-up visits will be scheduled through 36 months after initial treatment or touch-up.
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