drugset / Trial / NCT00765583

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

NCT00765583

Phase 4 Completed 75 enrolled Medicis Aesthetics, Inc.
RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2005-11
Primary completion
2008-12
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject HYALURONIC ACID (NON-ANIMAL STABILIZED) Unknown

Indications

No indication recorded.