Safety and Efficacy of Fillers for Contouring the Jawline (NCT06336759) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Fillers for Contouring the Jawline
Canada40 participantsStarted 2021-11-11
Plain-language summary
The study's goal is to assess the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, in order to address concerns regarding contour deficiencies among patients seeking aesthetic treatments.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A score \> 1 on the Raspaldo Jawline Scale, as assessed by the treating physician at Baseline. A possible secondary deficit of the chin is allowed.
✓. Males and females aged \> 18 years.
✓. Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
✓. Signed and dated informed consent to participate in the study.
✓. If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Exclusion criteria
✕. Current pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\].
✕. Subjects presenting with known allergy to hyaluronic acid fillers or amide local anesthetics.
✕. Subjects presenting with porphyria.
✕. Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites.
✕. Subjects with history of bleeding disorders or subjects taking thrombolytics or anticoagulants.
✕. Subjects taking inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs \[NSAIDs\]), within 2 weeks before treatment.
What they're measuring
1
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
Timeframe: Baseline to Month 3
2
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale