Belotero Post Approval Study
Condition: Nasolabial Folds
Intervention: Belotero®
Intervention description: Hyaluronic acid dermal filler
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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