A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial… (NCT02818556) | Clinical Trial Compass
UnknownPhase 4
A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines
United States50 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients exhibiting moderate \[2\] to severe \[3\] superficial, vertical perioral lines on the 5-point Merz® validated scale for assessment of superficial perioral lines
* Females and males in good general health over the age of 18 years old
Must be willing to give and sign a HIPAA form, informed consent form and a photographic release form
* Patient is planning to undergo Restylane® Silk and Belotero Balance® injections
* For female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active\]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
* Negative urine pregnancy test results at the time of study entry (if applicable)
* Must be willing to comply with study regimen and complete the entire course of the study.
Exclusion Criteria:
* A patient with any uncontrolled systemic disease. A…
What they're measuring
1
Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale