Safety/Efficacy Study of Restylane® in Lip Augmentation

Lip Augmentation Clinical Trial

Official title:

A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935272
• Other study ID #: MA-1300-15
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: December 22, 2011
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2011
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lip Augmentation

Intervention

Device:
• Restylane®
Restylane® injections in the lips
• Non-Treatment
Non- Treatment

Locations

Country	Name	City	State
United States	Call for Information	Chapel Hill	North Carolina
United States	Call for Information	Chestnut Hill	Massachusetts
United States	Call for Information	Coral Gables	Florida
United States	Call for Information	Hunt valley	Maryland
United States	Call for Information	Miami Beach	Florida
United States	Call for Information	Mount Kisco	New York
United States	Call for Information	New Haven	Connecticut
United States	Call for Information	San Diego	California
United States	Call for Information	San Francisco	California
United States	Call for Information	Santa Monica	California
United States	Call for Information	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Response	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.	Baseline and at 8 weeks	No
Secondary	Percentage of Participants With a Response	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.	Baseline and at weeks 12, 16, 20 and 24	No