Open-label, Multi-center, Randomized, Parallel-group, Post-Market Clinical Follow-Up Investigation to Evaluate the Clinical Performance and Safety of Belotero® Volume and Belotero® Volume Lidocaine for Chin Augmentation

Open-label, Multi-center, Randomized, Parallel-group, Post-Market Clinical Follow-Up Investigation to Evaluate the Clinical Performance and Safety of Belotero® Volume and Belotero® Volume Lidocaine for Chin Augmentation - BeVoC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031802

Enrollment

114

Registered

2023-05-30

Start date

2022-06-28

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chin augmentation

Interventions

Group 1: Subjects will be injected with a single treatment of Belotero Volume in the chin area. An optional touch-up injection is proposed at Week 4. Group 2: Subjects will be injected with a single t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Willing to abstain from all procedures in the face during the study - Subject with a G-Sn-Pg angle of 155° to 170° at Screening visit

Exclusion criteria

Exclusion criteria: - Severe microgenia - Previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid, chin-implants or other permanent dermal fillers below the nose - Surgeries below the nose and facial surgeries in the last 2 years that could potentially affect the area of the chin - Treatment with dermal therapies in the chin area within the past 3 months - Actinic damaged skin and/or premature skin aging in the area to be treated - Acute inflammatory process or infection at the injection site or history of chronic or recurrent infection or inflammation with potential to interfere with study results or increase risk of adverse events (AEs) - Any medical condition with the potential to interfere with the study or increase risk of AEs

Design outcomes

Primary

Measure	Time frame
• Change from Baseline to Week 12 after last injection in chin volume. It is measured by a validated 3D facial imaging method for volume measurement.	—

Secondary

Measure	Time frame
• Change from Baseline to Week 12 after last injection in the glabella-subnasal-pogonion (G-Sn-Pg) angle • Proportion of responders on the Merz Aesthetic Scale for Chin Projection at Week 12 after last injection as assessed by the investigator. Response is defined as at least a 1-point improvement compared to Baseline . • Investigator’s Global Aesthetic Improvement Scale (iGAIS) at Week 12 after last injection • Subject’s Global Aesthetic Improvement Scale (sGAIS) at Week 12 after last injection • Change from Baseline to Week 12 after last injection on Rasch-transformed FACE Q: Satisfaction with Chin • Incidence of treatment-emergent adverse events (TEAEs) related to treatment	—

Measure

Time frame

• Change from Baseline to Week 12 after last injection in the glabella-subnasal-pogonion (G-Sn-Pg) angle • Proportion of responders on the Merz Aesthetic Scale for Chin Projection at Week 12 after last injection as assessed by the investigator. Response is defined as at least a 1-point improvement compared to Baseline . • Investigator’s Global Aesthetic Improvement Scale (iGAIS) at Week 12 after last injection • Subject’s Global Aesthetic Improvement Scale (sGAIS) at Week 12 after last injection • Change from Baseline to Week 12 after last injection on Rasch-transformed FACE Q: Satisfaction with Chin • Incidence of treatment-emergent adverse events (TEAEs) related to treatment

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026