Safety and Efficacy of Fillers for Contouring the Jawline

NCT06336759 | Completed

• 1 other identifier: 2021-10-GAL-JWL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Jawline Contour Deficit

Keywords

Jawline; Injectables; Hyaluronic Acid; Aesthetic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)

  Baseline to Month 6

• Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale

  Baseline to Month 6

Study Arms (2)

Retylane Defyne

ACTIVE COMPARATOR

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

Retylane Lyft

ACTIVE COMPARATOR

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

Interventions

Restylane Defyne DEVICE

Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.

Retylane Defyne

Restylane Lyft DEVICE

Twenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft.

Retylane Lyft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects using immunosuppressants.
• History of permanent implants in the lower face.
• 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.
• Visible markings that in the treating investigator's opinion, may interfere with results or assessments.
• Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period.
• Heavy smokers, classified as smoking more than 12 cigarettes per day.
• History of severe or multiple allergies manifested by anaphylaxis.
• 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.
• Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3R3A1, Canada

Location

Study Officials

• Andreas Nikolis, MD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: November 11, 2021
• Primary Completion: December 14, 2022
• Study Completion: November 10, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)