A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit

Sinclair Pharmaceuticals Limited1 site in 1 country192 target enrollmentApril 30, 2024

ConditionsJawline Contour Deficit

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jawline Contour Deficit
Sponsor: Sinclair Pharmaceuticals Limited
Enrollment: 192
Locations: 1
Primary Endpoint: Efficacy rate of jawline contour deficit improvement in the test group at 48 weeks after the last injection and that in the control group at 48 weeks after randomization, evaluated by blinded evaluators using the MJAS.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit

Registry

clinicaltrials.gov

Start Date

April 30, 2024

End Date

April 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinclair Pharmaceuticals Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who aged 18 years or older (subject to the date of signing the informed consent), male or female;
•Subjects with a MJAS score of moderate to severe levels (2\~3 scores) in terms of bilateral jawline contour as evaluated by the blinded evaluator, and the scores of bilateral jawline contour must meet the criteria but not required to be the same;
•Subjects who are seeking to receive corrective treatment for jawline contouring;
•Subjects who are in good health and suitable to receive corrective treatment for jawline contouring as evaluated by the blinded evaluator;
•Subjects who voluntarily sign the ICF, understand and accept the study duration, and are able to comply with all requirements including treatment, follow-ups and other study procedures as scheduled;

Exclusion Criteria

•Subjects with non-aging skin laxity and lipoatrophy which may affect the evaluation of efficacy in the midface or mandibular region as identified by the investigator;
•Subjects who are known to be allergic to any local anesthetics (such as lidocaine or other amide anesthetics), or have a history of severe allergic reactions or anaphylactic shock;
•Subjects who have residual defects, scars, deformities, tattoos, perforations, hair, unhealed wounds, active skin diseases or inflammations (such as eczema, acnes, psoriasis, and herpes zoster), abscesses, carcinogenesis or precancerous lesions and other conditions that may affect evaluation of vision and efficacy or increase the risk of treatment in the injection and evaluation areas;
•Subjects with unstable and/or irreproducible malocclusion, or bruxism, hypertrophy or asymmetry of masseter, lockjaw, active temporomandibular disorders or active periodontal diseases;
•Subjects who have a tendency to develop keloids, hypertrophic scars, or any other healing disorders.

Outcomes

Primary Outcomes

Efficacy rate of jawline contour deficit improvement in the test group at 48 weeks after the last injection and that in the control group at 48 weeks after randomization, evaluated by blinded evaluators using the MJAS.

Time Frame: 48 weeks

Secondary Outcomes

Efficacy rate of jawline contour deficit improvement (as evaluated by blinded evaluators, except for the primary efficacy index visit point)(5, 12, 24 and 36 weeks)
Jawline contour deficit improvement score (as evaluated by blinded evaluators)(5, 12, 24, 36 and 48 weeks)
Change in FACE-QTM Satisfaction with Lower Face and Jawline score from the baseline (as evaluated by the subject)(5, 12, 24 36 and 48 weeks)