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Safety/Efficacy Study of Restylane® in Lip Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00935272
First received: July 7, 2009
Last updated: December 22, 2011
Last verified: December 2011
History of Changes

July 7, 2009
December 22, 2011
July 2009
June 2010   (final data collection date for primary outcome measure)
Percentage of Participants With Response [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Blind (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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935272
MA-1300-15
No
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