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A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.

NCT00765583 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2011-09-22

No results posted yet for this study

Summary

A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.

Conditions

  • Rhytids

Interventions

DRUG

Restylane

Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.

Sponsors & Collaborators

  • Medicis Aesthetics, Inc.

    lead INDUSTRY

Principal Investigators

  • Fredric Brandt, MD · Dermatology Research Institute, LLC

  • Steven Dayan, MD · Steven Dayan, MD

  • Rhoda narins, MD · Rhoda narins, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-12-31
Completion
2009-02-28

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 NCT00765583 on ClinicalTrials.gov