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

NCT ID: NCT03319719

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2017-12-06

Brief 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.

Conditions

Correction of Moderate to Severe Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Belotero® Balance with integral lidocaine

Belotero® Balance with integral lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized)

Group Type: EXPERIMENTAL

Belotero® Balance with integral lidocaine

Intervention Type: DEVICE

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

Belotero Balance without lidocaine

Belotero Balance without lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized)

Group Type: ACTIVE_COMPARATOR

Belotero® Balance

Intervention Type: DEVICE

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

Interventions

Belotero® Balance with integral lidocaine

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

Intervention Type: DEVICE

Belotero® Balance

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

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic acid dermal filler with lidocaine, single use syringe; Hyaluronic acid dermal filler, single use syringe

Eligibility Criteria

Inclusion Criteria

1. Has right and left NLF ratings of 2 or 3 (moderate or severe) on the Merz NLF Scale, as determined by the blinded evaluator.

2. Has the same Merz NLF Scale rating on both NLFs (i.e., symmetrical NLFs).

3. Is at least 18 years of age.

4. Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage], or surgical procedures) below the orbital rim on the face during study participation.

Exclusion Criteria

1. Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrollment.)

2. Has skin or fat atrophy, beyond typical for the subject's age, in the mid- to lower-facial region or has been diagnosed with a connective tissue disorder.

3. Has unphysiological skin laxity or sun damage, beyond typical for the subject's age, or subject plans to tan during the study period.

4. Has undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to receive such surgery during participation in the study.

5. Has received mid- and/or lower-facial region treatments with porcine-based collagen fillers, Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, poly L-lactic acid (PLLA), or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatment during participation in the study.

6. Has ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the mid- and/or lower-facial region or plans to receive such treatment during participation in the study.

7. Has received immunosuppressive medications or systemic steroids (except intranasal/inhaled steroids) in the past 2 months or plans to receive such treatment during participation in the study.

8. Has an acute inflammatory process or infection at the injection site (e.g., skin eruptions such as cold sores, cysts, pimples, acne, eczema, hives, streptococcus infections) or history of chronic or recurrent infection or inflammation with the potential to interfere with study results or increase the risk of AEs.

9. Has a history of allergic/anaphylactic reactions, including hypersensitivity to lidocaine or anesthetics of the amide type, hyaluronic acid preparations, gram positive bacterial proteins, or any of the device components.

10. Has a known bleeding disorder or has received or is planning to receive anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs [e.g., aspirin, ibuprofen]), or other substances known to increase coagulation time (e.g., vitamins or herbal supplements, i.e., Vitamin E, garlic, gingko) from 10 days before injection to 3 days after injection.

11. Has any other medical condition with the potential to interfere with study outcome assessments or compromise subject safety (i.e., increase the risk of adverse events).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kreymerman, MD, FACS

Role: STUDY_DIRECTOR

Merz North America, Inc.

Locations

Center for Dermatology and Dermatology Surgery; Merz Investigational Site #0010170

Washington D.C., District of Columbia, United States

Tennessee Clinical Research Center; Merz Investigational Site #0010097

Nashville, Tennessee, United States

Research Across America (Synexus); Merz Investigational Site #0010125

Plano, Texas, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

M930021001

Identifier Type: -

Identifier Source: org_study_id