Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03319719 · ClinicalTrials.gov registry record · NA
Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
A NA study, sponsored by Merz North America.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT03319719: Completed NA study, sponsored by Merz North America.
NCT03319719 is a NA study that has completed, run by Merz North America. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319719, a NA study, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.
Interventions
- DEVICE Belotero® Balance with integral lidocaine
- DEVICE Belotero® Balance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2017-12-06 |
| Phase | NA |
What the finished NCT03319719 record still lists
NCT03319719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Belotero® Balance with integral lidocaine is the first listed.
NCT03319719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03319719 about?
NCT03319719 is a clinical study titled "Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds". 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) duri...
What is the current status of trial NCT03319719?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2017-09-18. Estimated completion is 2017-12-06.
What interventions are being tested in trial NCT03319719?
The interventions under investigation include: Belotero® Balance with integral lidocaine (DEVICE), Belotero® Balance (DEVICE).
Who is sponsoring clinical trial NCT03319719?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03319719's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI