N/A
N=60
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT00823069 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm — 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perlane and Perlane-L (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medicis Global Service Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm |
95 | — |
| SECONDARY Number of Subjects Showing Wrinkle Improvement at Day 14 |
57; 58 | — |
Summary
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
Eligibility Criteria
Inclusion Criteria
- Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])
Exclusion Criteria
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- 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 Nasolabial Fold area
Data sourced from ClinicalTrials.gov (NCT00823069). 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.