Phase 4 N=20 Treatment

Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

Peri-oral Wrinkles

Bottom Line

View on ClinicalTrials.gov: NCT00977704 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcome: Primary: Local and Systemic Adverse Events — 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Restylane and Perlane (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medicis Global Service Corporation
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Local and Systemic Adverse Events	100	—

Summary

This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.

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

View full record on ClinicalTrials.gov →

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.