A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Restylane arm with different re-treatment schedules
Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.
Other Name: restylane
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.
|United States, Florida|
|Dermatology Research Institute, LLC|
|Coral Gables, Florida, United States, 33146|
|United States, Illinois|
|Dayan Facial Plastic Surgery Institute|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Rhoda Narins, MD|
|White Plains, New York, United States, 10604|
|Principal Investigator:||Fredric Brandt, MD||Dermatology Research Institute, LLC|
|Principal Investigator:||Steven Dayan, MD||Steven Dayan, MD|
|Principal Investigator:||Rhoda narins, MD||Rhoda narins, MD|