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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
Dayan Facial Plastic Surgery Institute
Chicago, Illinois, United States
Rhoda Narins, MD
White Plains, New York, United States
Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18.
Time frame: 18 months
Subject and Blinded Evaluator WSRS scores at all other time points and Treating Investigator and Subject Global Aesthetic Improvement Scores (GAIS) at all time points.
Time frame: Through end of study
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