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

NCT06391580 | Not Yet Recruiting DMC

• 1 other identifier: HDM6010A-301
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

No treatment control

NO INTERVENTION

No treatment control

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinclair Pharmaceuticals Limited: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

• Hongyi Zhao

  Beijing Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MENG YAN

CONTACT

020-89168071; clinical.development@sinclairaesthetics.com

ZHONGXING ZHANG

CONTACT

020-89168071; Medical.Committee@sinclairaesthetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)