Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.
The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Filler Line and Dysport Neuromodulator | Experimental | This study will consist of an open-label, prospective, cohort trial design. Twenty-four subjects will be recruited. Subjects will be recruited based on their primary deficit, 8 subjects will have a primary deficit in lip volume, 8 subjects will have a primary deficit in lip framing and 8 subjects will have a primary deficit in expression. All subjects will receive active treatment with hyaluronic acid at Baseline, with an optional touch at week two. There will be no placebo or no-treatment control groups. Subjects will be followed for five months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane line of soft tissue fillers and Dysport neuromodulator | Device | Subjects will be treated with a range of hyaluronic acid-based soft tissue fillers (Restylane line) and Dysport neuromodulator |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | Frequency of subjects having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator. Grading value varies from worse (grading of -1) to very much improved (grading of 3). | Baseline to Week 2, Week 4, Week 8, Week 20 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Uncontrolled systemic disease
Subjects do not present with or have a history of any medical condition that may place the subject at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study medical device
History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)
Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed
Subject has anticipated need for surgery or overnight hospitalization during the study.
History of surgical procedures in the face including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
Subject has a history of facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
Subjects is presenting with porphyria
Subjects has present with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites
Subject has bleeding disorders or take thrombolytics or anticoagulants
Subjects has had known active COVID infection within 30 days of treatment
Female subjects that are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
Subjects has been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study.
Subject must take immunosuppressant medication
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, MD | Erevna Innovations Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc. | Montreal | Quebec | H3R3A1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided