Jawline Contour Deficit
Conditions
Keywords
Jawline, Injectables, Hyaluronic Acid, Aesthetic
Brief 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.
Interventions
DEVICERestylane Defyne
Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.
DEVICERestylane Lyft
Twenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft.
Sponsors
Erevna Innovations Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Males and females aged \> 18 years. 3. 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. 4. Signed and dated informed consent to participate in the study. 5. If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Exclusion criteria
1. Current pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\]. 2. Subjects presenting with known allergy to hyaluronic acid fillers or amide local anesthetics. 3. Subjects presenting with porphyria. 4. Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites. 5. Subjects with history of bleeding disorders or subjects taking thrombolytics or anticoagulants. 6. Subjects taking inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs \[NSAIDs\]), within 2 weeks before treatment. 7. Subjects using immunosuppressants. 8. History of permanent implants in the lower face. 9. History of other treatment/procedure that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation. 10. Visible markings that in the treating investigator's opinion, may interfere with results or assessments. 11. Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period. 12. Heavy smokers, classified as smoking more than 12 cigarettes per day. 13. History of severe or multiple allergies manifested by anaphylaxis. 14. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion. 15. Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment. 16. Previous treatment with soft tissue fillers in the area under assessment, within 12 months prior to enrolment. 17. Cancer or precancer in the treatment area (e.g., actinic keratosis). 18. Subjects with a tendency to form hypertrophic scars or any other healing disorders. 19. Subjects with a mean skin thickness in the treatment areas between 1.29mm and 1.49mm (ie, normal thickness), as determined by ultrasound at Baseline, to ensure no overlap between the two strata (ie, thin and thick skin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of subjects having at least improved since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) | Baseline to Month 3 | The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form very much worse (grade -3) to very much improved (grade 3). |
| Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale | Baseline to Month 3 | The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from severe depression or atrophy (grade 4) to normal (grade 1) used by the blinded evaluator to assess the jawline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of subjects having at least improved since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) | Baseline to Month 6 | The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form very much worse (grade -3) to very much improved (grade 3). |
| Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale | Baseline to Month 6 | The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from severe depression or atrophy (grade 4) to normal (grade 1) used by the blinded evaluator to assess the jawline |
Countries
Canada
Outcome results
None listed