A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765583
|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|