A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.
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|ClinicalTrials.gov Identifier: NCT00765583|
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : September 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rhytids||Drug: Restylane||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||February 2009|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|