Skip to main content
OpenTrials
Completed

NCT Number: NCT00935272

Safety/Efficacy Study of Restylane® in Lip Augmentation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lip Augmentation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Call for Information, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane®

Device

Restylane® injections in the lips

Non-Treatment

Device

Non- Treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.