A Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit

Sinclair Pharmaceuticals Limited

Status

Not yet enrolling

Conditions

Jawline Contour Deficit

Treatments

Device: Poly-L-lactin Acid (PLLA) Based Facial Injectable

Study type

Interventional

Funder types

Industry

Identifiers

NCT06391580

HDM6010A-301

Details and patient eligibility

About

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

Enrollment

192 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.