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Belotero Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635855
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: Belotero® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Belotero® Post Approval Study for the Treatment of Nasolabial Folds
Study Start Date : June 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Belotero
Belotero® Hyaluronic acid dermal filler
 Device: Belotero®
Hyaluronic acid dermal filler


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Severe Common Adverse Events [ Time Frame: 1 month ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635855


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
Los Angeles, California, United States, 90069
Los Angeles, California, United States
San Francisco, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, Maryland
Glen Dale, Maryland, United States
United States, New Jersey
Montclair, New Jersey, United States
United States, New York
White Plains, New York, United States
Sponsors and Collaborators
Merz North America, Inc.
More Information
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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01635855    
Other Study ID Numbers: P110637
First Posted: July 10, 2012    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014
Last Verified: July 2014