Belotero Post Approval Study

Belotero® Post Approval Study for the Treatment of Nasolabial Folds

A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: Belotero®

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Los Angeles, California, United States
    • Los Angeles, California, United States, 90069
    • San Francisco, California, United States
  • Connecticut
    • New Haven, Connecticut, United States
  • Louisiana
    • Metairie, Louisiana, United States
  • Maryland
    • Glen Dale, Maryland, United States
  • New Jersey
    • Montclair, New Jersey, United States
  • New York
    • White Plains, New York, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Was a participant in the Belotero® Balance pre-market IDE clinical trial or the Belotero Balance Fitzpatrick Skin Type IV-VI Study.
2. Is a candidate for bilateral nasolabial fold re-treatment with Belotero® Balance.
3. Understands and accepts the obligation not to receive any other facial procedures from enrollment through 1 month from optimal correction in the current study.
4. Understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements.

Exclusion Criteria:

1. Has received surgery in either nasolabial fold.
2. Has received within the past 6 months a non-permanent filler (e.g. hyaluronic acid, CaHA) or neurotoxin below the zygomatic arch.
3. Has received at any time a permanent filler (e.g. polylactic acid, PMMA, silicone) below the zygomatic arch.
4. Has received within the past 6 months dermal resurfacing procedures (e.g. medium/deep chemical peel, dermabrasion treatments, ablative laser resurfacing) or non-invasive skin-tightening (e.g. Thermage) below the zygomatic arch.
5. Has received in the past 2 weeks prescription facial wrinkle therapies (e.g., RENOVA®), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) below the zygomatic arch.
6. Has received in the past 2 months or plans to receive during the study immunosuppressive medications or systemic steroids (intranasal / inhaled steroids acceptable).
7. Has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
8. Has a known bleeding disorder or is using medication that reduces blood coagulation, (e.g. aspirin, non-steroidal anti-inflammatory drugs, or warfarin) which may increase the risk of bleeding during the treatment session.
9. Has a known history of severe allergies manifested by a history of anaphylaxis; or history or presence of multiple severe allergies.
10. Has known allergy or hypersensitivity to hyaluronic acid preparations, gram positive bacterial proteins or Belotero® or Belotero® derivative.
11. Has a known history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
12. Is a female of childbearing potential (e.g. not post-menopausal for at least one year or has not had a hysterectomy or tubal ligation) and is pregnant, lactating or plans to become pregnant during the study or is not using medically effective birth control.
13. Has any other medical condition with the potential to interfere with the study or increase the risk of adverse events.
14. Is enrolled or plans to enroll in a competitive or interfering study.
15. Is an employee or direct relative of an employee of the investigational site or study sponsor.
16. All Fitzpatrick skin types are eligible for study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Belotero; Belotero® Hyaluronic acid dermal filler	Device: Belotero®; Hyaluronic acid dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Severe Common Adverse Events	The purpose of this study was to determine if the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies)."Common" is defined as pre-specified adverse events occurring in >= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.	1 month

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: P110637