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This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of RestylaneĀ® Silk (right side of the face) and Belotero BalanceĀ® (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Right, Belotero Left | Other | Patients will receive one treatment with RestylaneĀ® Silk (right side of the face) and one treatment of Belotero BalanceĀ® (left side) |
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| Restylane Left, Belotero Right | Other | Patients will receive one treatment with RestylaneĀ® Silk (left side of the face) and one treatment of Belotero BalanceĀ® (right side) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restalyne Silk | Drug |
| ||
| Belotero Balance |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Response to therapy as evaluated by investigator using 5-point MerzĀ® Scale | Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded evaluator: A 1-point improvement from baseline in superficial, vertical, perioral rhytids based on the 5-point MerzĀ® Scale | Day 0, 7, 14, 30, 60, 90, 120, 150, 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Therapy- Subject | Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded patient: A 20% improvement from baseline in superficial, vertical, perioral rhytids using a linear analog scale | Day 0, 7, 14, 30, 60, 90, 120, 150, 180 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Bass | Contact | (415)567-8275 | research@maasclinic.com | |
| Kyle Jennings | Contact | (415)567-7000 | research2@maasclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Corey S. Maas, M.D. | The Maas Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Maas Clinic | Recruiting | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| C584568 | belotero balance |
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| Drug |
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| Severity grading- Evaluator | Severity grading by a blinded evaluator employing standardized photography in combination with the 5-point MerzĀ® Scale | 6 months |
| VISIA complexion analysis | VISIA complexion analysis (Canfield Imaging Systems, Fairfield, New Jersey) on day 0 (initial treatment), day 30 and when the patient's perioral fine lines have returned to baseline. VISIA analysis will be used to grade the patient's skin by measuring the wrinkles and generating a percentile score. | Day 0, Day 30 |