Open-label, multicenter, uncontrolled, rater-blinded, post-market clinical follow up (PMCF) study to confirm performance and safety of Belotero® Soft Lidocaine and Belotero® Intense Lidocaine in the treatment of nasolabial folds, perioral fine lines and/or for lip volume enhancement

Open-label, multicenter, uncontrolled, rater-blinded, post-market clinical follow up (PMCF) study to confirm performance and safety of Belotero® Soft Lidocaine and Belotero® Intense Lidocaine in the treatment of nasolabial folds, perioral fine lines and/or for lip volume enhancement - BiSoLi

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031121

Enrollment

210

Registered

2023-03-01

Start date

2018-06-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Facial soft tissue augmentation

Interventions

Group 1: Subjects are to be injected in at least two treatment areas. Belotero Soft Lidocaine is administered to fill perioral fine lines, and Belotero Intense Lidocaine to fill nasolabial folds and e

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects seeking for hyaluronic acid (HA) dermal filler/volumizing treatment in the face to correct at least two of the following regions: a. Nasolabial folds; b. Upper and lower lip volume; and c. Perioral fine lines. Depending on the area to be treated, the following criteria apply: Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale (MNLFS) with symmetrical rating; Upper and lower lips volume deficit of very thin to moderately thick intensity (grade 0 to 2) on the Merz Lip Fullness Scale (MLFS); and Perioral fine lines with a rating of mild to moderate grading (grade 1 to 2) on the validated Merz Lip Wrinkle Scale (MLWS).

Exclusion criteria

Exclusion criteria: Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated; Prior treatment within the past 12 months with HA filler in the areas to be treated; and Prior treatment within the past three months with dermal therapies (e.g., toxin treatments, facial ablative or fractional laser, microdermabrasion, chemical peels, and non-invasive skin-tightening) in the areas to be treated.

Design outcomes

Primary

Measure	Time frame
•Responder rate for nasolabial folds after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the Merz Nasolabial Folds Scale (MNLFS). Response is defined as improvement of = 1 point on the MNLFS in both folds (left and right) at Week 12 or Week 16 if touch up is performed; •Responder rate for upper and lower lip fullness after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the Merz Lip Fullness Scale (MLFS). Response is defined as improvement of = 1 point on the MLFS in both lips (upper and lower) at Week 12 or Week 16 if touch up is performed. In case only one lip is treated the response is defined as improvement of = 1 point on the MLFS in treated lip; and •Responder rate for perioral fine lines after treatment with Belotero Soft Lidocaine based on the blinded rater’s evaluation on the Merz Lip Wrinkle Scale (MLWS). Response is defined as improvement of = 1 point on the MLWS at Week 8 or Week 12 if touch-up is performed.	—

Measure

Time frame

•Responder rate for nasolabial folds after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the Merz Nasolabial Folds Scale (MNLFS). Response is defined as improvement of = 1 point on the MNLFS in both folds (left and right) at Week 12 or Week 16 if touch up is performed; •Responder rate for upper and lower lip fullness after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the Merz Lip Fullness Scale (MLFS). Response is defined as improvement of = 1 point on the MLFS in both lips (upper and lower) at Week 12 or Week 16 if touch up is performed. In case only one lip is treated the response is defined as improvement of = 1 point on the MLFS in treated lip; and •Responder rate for perioral fine lines after treatment with Belotero Soft Lidocaine based on the blinded rater’s evaluation on the Merz Lip Wrinkle Scale (MLWS). Response is defined as improvement of = 1 point on the MLWS at Week 8 or Week 12 if touch-up is performed.

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Secondary

Measure	Time frame
Responder rate for nasolabial folds after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the MNLFS at Week 4 pre optional touch-up, at Week 8 if applicable, at Week 8/12, at Week 24/28, at Week 36/40, and at Week 48/52 depending on touch-up performed); Responder rate for upper and lower lip fullness after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the MLFS at Week 4 pre optional touch-up, at Week 8 if applicable, at Week 8/12, at Week 24/28, at Week 36/40, and at Week 48/52 (depending on touch-up performed). In case only one lip is treated the response is defined as improvement of = 1 point on the MLFS in treated lip; and Responder rate for perioral fine lines after treatment with Belotero Soft Lidocaine based on the blinded rater’s evaluation on the MLWS at Week 4 pre optional touch up, at Week 8 if applicable, at Week 12/16, at Week 24/28, at Week 36/40, and at Week 48/52 (depending on touch-up performed); and Treating investigator’s evaluation of the global aesthetic improvement on the iGAIS from Day 1 pre-injection photographs to Week 4 pre optional touch up, to Week 8 if applicable, to Week 8/12, to Week 12/16, to Week 24/28, to Week 36/40, and to Week 48/52; and Subject’s evaluation of the global aesthetic improvement on the sGAIS from Day 1 pre-injection photographs to Week 4 pre optional touch-up, to Week 8 if applicable, to Week 8/12, to Week 12/16, to Week 24/28, to Week 36/40, and to Week 48/52.	—

Measure

Time frame

Responder rate for nasolabial folds after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the MNLFS at Week 4 pre optional touch-up, at Week 8 if applicable, at Week 8/12, at Week 24/28, at Week 36/40, and at Week 48/52 depending on touch-up performed); Responder rate for upper and lower lip fullness after treatment with Belotero Intense Lidocaine based on the blinded rater’s evaluation on the MLFS at Week 4 pre optional touch-up, at Week 8 if applicable, at Week 8/12, at Week 24/28, at Week 36/40, and at Week 48/52 (depending on touch-up performed). In case only one lip is treated the response is defined as improvement of = 1 point on the MLFS in treated lip; and Responder rate for perioral fine lines after treatment with Belotero Soft Lidocaine based on the blinded rater’s evaluation on the MLWS at Week 4 pre optional touch up, at Week 8 if applicable, at Week 12/16, at Week 24/28, at Week 36/40, and at Week 48/52 (depending on touch-up performed); and Treating investigator’s evaluation of the global aesthetic improvement on the iGAIS from Day 1 pre-injection photographs to Week 4 pre optional touch up, to Week 8 if applicable, to Week 8/12, to Week 12/16, to Week 24/28, to Week 36/40, and to Week 48/52; and Subject’s evaluation of the global aesthetic improvement on the sGAIS from Day 1 pre-injection photographs to Week 4 pre optional touch-up, to Week 8 if applicable, to Week 8/12, to Week 12/16, to Week 24/28, to Week 36/40, and to Week 48/52.

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Countries

Germany

Outcome results

None listed

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