A Study of Belotero® Intense Lidocaine for Lip Augmentation (BILUS)

Merz Pharmaceuticals

Status: Active, not recruiting

Conditions: Lip Augmentation

Treatments: Device: Restylane® Silk; Device: Belotero® Intense Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05773066

M930041001

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.

Full description

For all subjects, standardized photographs of the lips will be taken at the screening visit (prior to treatment) and at multiple intervals throughout the study to be used for comparisons and study assessments.

Subjects will receive an injection of either BIL or Restylane Silk (RS) in the upper and/or lower lips. A touch-up injection will be given 4 weeks after the initial treatment if the subject fails to show improvement in 1 or both lips or if the subject does not achieve optimal aesthetic correction. Subjects treated with BIL have the option of a retreatment with BIL 48 weeks post last injection.

Enrollment: 220 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit

Exclusion criteria

Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face Has undergone oral surgery in the past 30 days Lip volume deficit due to medical conditions Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components

Trial design

220 participants in 2 patient groups

Belotero® Intense Lidocaine

Experimental group

Description:

Lips injected with BIL.

Treatment:

Device: Belotero® Intense Lidocaine

Restylane® Silk

Active Comparator group

Description:

Lips injected with RS.

Treatment:

Device: Restylane® Silk