A Phase 4 interventional study of Restalyne Silk and Belotero Balance in Perioral Rhytids, sponsored by The Maas Clinic. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-29.
Sponsored by The Maas Clinic · Phase 4, Interventional, and Treatment
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.
The Maas Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Patients will receive one treatment with Restylane® Silk (right side of the face) and one treatment of Belotero Balance® (left side)
Drug: Restalyne Silk · Drug: Belotero Balance
Patients will receive one treatment with Restylane® Silk (left side of the face) and one treatment of Belotero Balance® (right side)
Drug: Restalyne Silk · Drug: Belotero Balance
Change in Response to therapy as evaluated by investigator using 5-point Merz® 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 Merz® Scale
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
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
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Severity grading- Evaluator
Severity grading by a blinded evaluator employing standardized photography in combination with the 5-point Merz® Scale
Time frame: 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.
Time frame: Day 0, Day 30
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Maas Clinic