Clinical trial NCT06336759: Safety and Efficacy of Fillers for Contouring the Jawline
Official title: Prospective Clinical Trial Evaluating the Safety and Efficacy of Restylane Lyft and Defyne for Contouring the Jawline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jawline Contour Deficit
Keywords: Jawline
Injectables
Hyaluronic Acid
Aesthetic
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Baseline to Month 3
measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Baseline to Month 6
measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale
timeFrame: Baseline to Month 6
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Erevna Innovations Inc.
state: Quebec
Study officials:
affiliation: Erevna Innovations Inc.
name: Andreas Nikolis, MD
role: PRINCIPAL_INVESTIGATOR
References: