Phase 4
Completed N=20
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
Peri-oral Wrinkles
Source: ClinicalTrials.gov NCT00977704 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Local and Systemic Adverse Events — 100 percentage of participants
Summary
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local and Systemic Adverse Events |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids
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 (NCT00977704). 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. Informational only — not medical advice.