N/A N=180 Randomized Single-blind Treatment

Safety/Efficacy Study of Restylane® in Lip Augmentation

Lip Augmentation

Bottom Line

View on ClinicalTrials.gov: NCT00935272 ↗

Enrolled (actual)

180

Serious AEs

1.8%

Results posted

Jan 2012

Primary outcome: Primary: Percentage of Participants With Response — 92.6; 28.9 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane® (Device); Non-Treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medicis Global Service Corporation
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Response	92.6; 28.9	—
SECONDARY Percentage of Participants With a Response	90.1; 36.8; 84.2; 35.9; 75.0; 33.3	—

Summary

To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Eligibility Criteria

Inclusion Criteria

Must meet established lip fullness criteria

Exclusion Criteria

Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00935272). 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.