Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Must be willing to give and sign a HIPAA form, informed consent form and a photographic release form
Exclusion criteria
A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Central trial contact
Kyle Jennings; Rachel Bass
Data sourced from clinicaltrials.gov
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