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Safety/Efficacy Study of Restylane® in Lip Augmentation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935272
First Posted: July 9, 2009
Last Update Posted: January 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medicis Global Service Corporation
July 7, 2009
July 9, 2009
November 2, 2011
January 30, 2012
January 30, 2012
July 2009
June 2010   (Final data collection date for primary outcome measure)
Percentage of Participants With Response [ Time Frame: 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.
Blinded Evaluator assessment of lip fullness; incidence of all adverse events [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00935272 on ClinicalTrials.gov Archive Site
Percentage of Participants With a Response [ Time Frame: 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.
Blinded Evaluator and Treating Investigator assessment of lip fullness; subject satisfaction; lip safety [ Time Frame: All time points, excluding week 8 ]
Not Provided
Not Provided
 
Safety/Efficacy Study of Restylane® in Lip Augmentation
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
To determine the safety and effectiveness of Restylane® when used for lip augmentation.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Lip Augmentation
  • Device: Restylane®
    Restylane® injections in the lips
  • Device: Non-Treatment
    Non- Treatment
  • Experimental: Treatment
    Restylane® Treatment
    Intervention: Device: Restylane®
  • No Intervention: Non-Treatment
    Non-Treatment Arm
    Intervention: Device: Non-Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
July 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00935272
MA-1300-15
No
Not Provided
Not Provided
Medicis Global Service Corporation
Medicis Global Service Corporation
Not Provided
Study Chair: Heather Corey, MBA Medicis Global Service Corporation
Medicis Global Service Corporation
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP