Safety and Efficacy of Fillers for Contouring the Jawline

Prospective Clinical Trial Evaluating the Safety and Efficacy of Restylane Lyft and Defyne for Contouring the Jawline

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.

Study Overview

• Status: Completed
• Conditions: Jawline Contour Deficit
• Intervention / Treatment: Device: Restylane Defyne; Device: Restylane Lyft

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3R3A1
      • Erevna Innovations Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Retylane Defyne; Restylane Defyne is manufactured by Q-Med AB, part of the Galderma Group. The product is a sterilized 1ml gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7). The participants deemed to have think skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator.	Device: Restylane Defyne; Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.
Active Comparator: Retylane Lyft; Restylane Defyne is manufactured by Q-Med AB, part of the Galderma Group. The product is a sterilized 1mL gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7). The participants deemed to have thick skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator.	Device: Restylane Lyft; Twenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)	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).	Baseline to Month 3
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale	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	Baseline to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)	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).	Baseline to Month 6
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale	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	Baseline to Month 6

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.
• Investigators: Principal Investigator: Andreas Nikolis, MD, Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Aesthetic; Injectables; Jawline
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2021-10-GAL-JWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No