N/A
N=60
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT00797459 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Treatment Difference in Pain as Measured by a Visual Analogue Scale — 44.9; 14.7 Scores on a VAS Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane and Restylane-L (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medicis Global Service Corporation
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Difference in Pain as Measured by a Visual Analogue Scale |
44.9; 14.7 | — |
| SECONDARY Wrinkle Improvement at Day 14 |
60; 59 | — |
Summary
Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
Eligibility Criteria
Inclusion Criteria
- Subjects seeking augmentation therapy for correction of bilateral NLFs
- Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
- Subjects willing to give written informed consent to participate in the study
- Women of childbearing potential willing to use an acceptable form of birth control during the study period
Exclusion Criteria
- Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
- Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the NLF area
Data sourced from ClinicalTrials.gov (NCT00797459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.