Safety/Efficacy Study of Restylane® in Lip Augmentation

Not Applicable

Completed

• Conditions: Lip Augmentation
• Interventions: Device: Restylane®; Device: Non-Treatment

• Registration Number: NCT00935272
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-09
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2011-11-02
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-22
• Last Update Submitted: 2011-12-22
• Results First Posted: 2012-01-30
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Restylane®	Restylane® Treatment
Non-Treatment	Non-Treatment	Non-Treatment Arm

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response	Baseline and at 8 weeks	Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Response	Baseline and at weeks 12, 16, 20 and 24	Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.

Trial Locations

Locations (1)

Call for Information; 🇺🇸 Chapel Hill, North Carolina, United States