CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Belotero® Balance with integral lidocaine +1 moredevice
Likely dose
Belotero® Balance with integral lidocaine or Belotero® Balance: 3 mL maximum per nasolabial fold over two treatment sessions via intradermal injection.AI-extracted
Key inclusion· 4
  • ✓At least 18 years of age.
  • ✓Moderate or severe nasolabial fold severity (Merz scale 2 or 3) on both right and left folds, as assessed by blinded evaluator.
  • ✓Symmetrical nasolabial fold severity on both sides (same Merz rating bilaterally).
  • ✓Willing to avoid other facial procedures (dermal fillers, toxin, laser, microdermabrasion, chemical peels, non-invasive skin-tightening, or surgery) below the orbital rim during study participation.
Key exclusion· 10
  • ✕Prior mid/lower-face surgery including nasolabial fold treatment, or presence of permanent implants/grafts in mid/lower-face that could interfere with assessments (exception: rhinoplasty ≥12 months prior permitted).
  • ✕Skin or fat atrophy beyond typical for age in mid-to-lower face, or diagnosed connective tissue disorder.
  • ✕Unphysiological skin laxity or sun damage beyond typical for age, or plans to tan during study.
  • ✕Oral surgery (orthodontia, extraction, implants) within past 30 days or planned during study participation.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03319719
NCT03319719N/ACompleted
CompareCT.gov

Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds

Merz North America, Inc.·interventional·Posted Oct 24, 2017·Updated Oct 1, 2019

In Brief

A clinical study evaluating Belotero® Balance with integral lidocaine and Belotero® Balance for Correction of Moderate to Severe Nasolabial Folds. Completed, enrolled 52 participants across 3 sites.

Detailed Summary

Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs. Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorrection of Moderate to Severe Nasolabial Folds
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 24, 2017
Enrollment StartSep 18, 2017
Primary CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.7 years ago

Interventions

Belotero® Balance with integral lidocainedevice

Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.

Belotero® Balancedevice

Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.