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
- Conditions
- Facial soft tissue augmentation
- Registration Number
- DRKS00031121
- Lead Sponsor
- Merz Aesthetics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 220
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).
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •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;<br>•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<br>•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.
- Secondary Outcome Measures
Name Time Method