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

NCT00797459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-09-06

Study results available
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Summary

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

Conditions

  • Nasolabial Folds

Interventions

DEVICE

Restylane and Restylane-L

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

Sponsors & Collaborators

  • Q-Med Scandinavia, Inc.

    collaborator INDUSTRY

  • Medicis Global Service Corporation

    lead INDUSTRY

Principal Investigators

  • David Bank, MD · The Center for Dermatology, Cosmetic and Laser Surgery

  • Fredric Brandt, MD · Dermatology Research Institute LLC

  • Robert Weiss, MD · Maryland Laser Skin and Vein Institute

  • Ron Staugaard · Medicis Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-01-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00797459 on ClinicalTrials.gov