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Completed

NCT Number: NCT00797459

Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

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Key information

Conditions

Nasolabial Folds

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Research Institute LLC, Coral Gables, Florida, United States

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About this study

A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects seeking augmentation therapy for correction of bilateral NLFs
  • Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
  • Subjects willing to give written informed consent to participate in the study
  • Women of childbearing potential willing to use an acceptable form of birth control during the study period

Exclusion criteria

  • Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
  • Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
  • Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
  • Permanent implant placed in the NLF area

Treatment and study plan

Restylane and Restylane-L

Device

This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.

Primary outcomes

  1. Treatment Difference in Pain as Measured by a Visual Analogue Scale

    Time frame: After Injection on Day of Treatment

    No pain is noted at 0 mm and worst pain is noted at 100 mm.

Secondary outcomes

  1. Wrinkle Improvement at Day 14

    Time frame: 14 days after treatment when compared to baseline

    This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Collaborators

  • Q-Med Scandinavia, Inc.

Registry information

Official study title

A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2008
Registry last updated
Sep 6, 2013

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.

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