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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Jawline Contour Deficit
• Intervention / Treatment: Device: Poly-L-lactin Acid (PLLA) Based Facial Injectable

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MENG YAN; Phone Number: 020-89168071; Email: clinical.development@sinclairaesthetics.com
• Study Contact Backup: Name: ZHONGXING ZHANG; Phone Number: 020-89168071; Email: Medical.Committee@sinclairaesthetics.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Hospital
      • Contact: Hongyi Zhao; Email: zhaohy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Poly-L-lactin Acid (PLLA) Based Facial Injectable	Device: Poly-L-lactin Acid (PLLA) Based Facial Injectable; Poly-L-lactin Acid (PLLA) Based Facial Injectable
No Intervention: No treatment control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sinclair Pharmaceuticals Limited
• Investigators: Principal Investigator: Hongyi Zhao, Beijing Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HDM6010A-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No