drugset / Trial / NCT02818556

A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines

NCT02818556 ↗

Phase 4 Unknown 50 enrolled The Maas Clinic
RandomizedParallel-groupTriple-blindTreatment

Summary

This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.

Timeline

Start
2016-06
Primary completion
2017-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Belotero Balance Unknown — Other
Subject Restalyne Silk Unknown — Other