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

NCT ID: NCT06391580

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-04-30

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

Conditions

Jawline Contour Deficit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

No treatment control

No treatment control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects who aged 18 years or older (subject to the date of signing the informed consent), male or female;

2. 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;

3. Subjects who are seeking to receive corrective treatment for jawline contouring;

4. Subjects who are in good health and suitable to receive corrective treatment for jawline contouring as evaluated by the blinded evaluator;

5. 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

1. 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;

2. 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;

3. 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;

4. Subjects with unstable and/or irreproducible malocclusion, or bruxism, hypertrophy or asymmetry of masseter, lockjaw, active temporomandibular disorders or active periodontal diseases;

5. Subjects who have a tendency to develop keloids, hypertrophic scars, or any other healing disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinclair Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongyi Zhao

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital, China

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

MENG YAN

Role: CONTACT

clinical.development@sinclairaesthetics.com

020-89168071

ZHONGXING ZHANG

Role: CONTACT

Medical.Committee@sinclairaesthetics.com

020-89168071

Facility Contacts

Hongyi Zhao

Role: primary

zhaohy@163.com

Other Identifiers

HDM6010A-301

Identifier Type: -

Identifier Source: org_study_id