Belotero Post Approval Study

Completed · Phase 4

Conditions studied: Nasolabial Folds

In brief

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.

Key facts

Study ID

NCT01635855

Run by

Merz North America, Inc.

People needed

117

Starts

2012-06-01

Expected to finish

2012-11-01

Last updated by the study team

2014-07-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Has received surgery in either nasolabial fold.
• Has received within the past 6 months a non-permanent filler (e.g. hyaluronic acid, CaHA) or neurotoxin below the zygomatic arch.
• Has received at any time a permanent filler (e.g. polylactic acid, PMMA, silicone) below the zygomatic arch.
• 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.
• 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.
• Has received in the past 2 months or plans to receive during the study immunosuppressive medications or systemic steroids (intranasal / inhaled steroids acceptable).
• 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.
• 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.
• Has a known history of severe allergies manifested by a history of anaphylaxis; or history or presence of multiple severe allergies.
• Has known allergy or hypersensitivity to hyaluronic acid preparations, gram positive bacterial proteins or Belotero® or Belotero® derivative.
• Has a known history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
• 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.
• Has any other medical condition with the potential to interfere with the study or increase the risk of adverse events.
• Is enrolled or plans to enroll in a competitive or interfering study.
• Is an employee or direct relative of an employee of the investigational site or study sponsor.
• All Fitzpatrick skin types are eligible for study participation

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Metairie, Louisiana, United States
• Study site — Glenn Dale, Maryland, United States
• Study site — Montclair, New Jersey, United States
• Study site — White Plains, New York, United States

Full record on ClinicalTrials.gov

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