Safety and Efficacy of Fillers for Contouring the Jawline | NCT06336759

NCT06336759

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Restylane Defyne	Device	Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.	Retylane Defyne

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.
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.
Previous treatment with soft tissue fillers in the area under assessment, within 12 months prior to enrolment.
Cancer or precancer in the treatment area (e.g., actinic keratosis).
Subjects with a tendency to form hypertrophic scars or any other healing disorders.
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).