Clinical trial NCT06391580: A Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Jawline Contour Deficit
Lead sponsor: Sinclair Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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.
timeFrame: 48 weeks
Secondary outcomes:
measure: Efficacy rate of jawline contour deficit improvement (as evaluated by blinded evaluators, except for the primary efficacy index visit point)
timeFrame: 5, 12, 24 and 36 weeks
measure: Jawline contour deficit improvement score (as evaluated by blinded evaluators)
timeFrame: 5, 12, 24, 36 and 48 weeks
measure: Change in FACE-QTM Satisfaction with Lower Face and Jawline score from the baseline (as evaluated by the subject)
timeFrame: 5, 12, 24 36 and 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital, China
name: Hongyi Zhao
role: PRINCIPAL_INVESTIGATOR
References: