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A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow

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ClinicalTrials.gov Identifier: NCT03777917
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Brief Summary:
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows

Condition or disease Intervention/treatment Phase
Correction of Volume Loss in the Infraorbital Hollow Area Device: Belotero Balance® Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Belotero Balance® Device: Belotero Balance®
Up to 1.0 mL Belotero® Balance per infraorbital hollow (plus up to 0-5 mL per infraorbital hollow during touch-up 1month after baseline injection, as required). Mode of application: subdermal injection.

No Intervention: No treatment



Primary Outcome Measures :
  1. Comparison of the responder rate between the treatment group and the untreated control group at Month 2, according to the Merz Infraorbital Hollow Assessment Scale (MIHAS) as assessed by a blinded evaluator. [ Time Frame: From baseline to Month 2 ]
    The MIHAS is a 5-grade scale.


Secondary Outcome Measures :
  1. Summary of the FACE-Q satisfaction with eyes scores for treated subjects at baseline and Month 2 post last injection (i.e., either baseline treatment or touch-up, if applicable) and for control subjects at baseline and Month 2. [ Time Frame: Month 2 ]
  2. Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Month 2 post last injection (i.e., either baseline treatment or touch-up, if applicable), as completed by the treating investigator. [ Time Frame: Month 2 ]
  3. Descriptive summary of GAIS scores for treated subjects at Month 2 post last injection (i.e., either baseline treatment or touch-up, if applicable), as completed by the subject. [ Time Frame: Month 2 ]
    The Investigator-GAIS is a 7-point scale.

  4. Summary of the responder rates in the treatment group and the control group at Month 2, according to the MIHAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs), using subject photographs [ Time Frame: Month 2 ]
    The MIHAS is a 5-grade scale.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has right and left IOH volume deficit with a rating of 2 or 3 (moderate or severe) on the MIHAS, as determined by the blinded evaluator. The treating investigator must agree that the subject meets this criterion of a 2 or 3 rating on the MIHAS.
  • Has the same MIHAS score on both IOHs (i.e., IOHs are symmetrical).
  • Is at least 22 years of age.
  • 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] and surgical procedures) in the face during participation in the study.

Exclusion Criteria:

  • Prior lower-eyelid surgery, including orbital or midface surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments or plans to have it during the study.
  • Has gained or lost ≥ 2 body mass index (BMI) units within the previous 90 days or has the intention to gain or lose a significant amount of weight during the first 90 days of the study.
  • Ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region or plans to receive such treatments during participation in the study.
  • Received lower eyelid and/or malar region treatments with any absorbable or temporary fillers such as porcine-based collagen fillers, hyaluronic acid (HA) products, RADIESSE®, poly L-lactic acid (PLLA) or received mesotherapy treatment to the area within the past 24 months or plans to receive such treatments during participation in the study.
  • Any current or history of uncontrolled retinal disease or detached retina or any other condition with the potential to cause a decline of visual acuity (e.g., uncontrolled diabetes).
  • Received deep facial dermal therapies (i.e., facial ablative or fractional laser, deep chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage]) to the periorbital or malar region within the past 12 months or plans to receive such treatment during participation in the study.
  • Received superficial facial dermal therapies (i.e., microderm abrasion, superficial chemical peels) to the periorbital or malar region within the past 6 months or plans to receive such treatment during participation in the study.
  • Received toxin treatment to the periorbital region within the past 6 months or plans to receive such treatment during participation in the study.
  • Received immunosuppressive medications or systemic steroids (except intranasal/inhaled steroids) in the past 2 months or plans to receive them during participation in the study.
  • Tendency to accumulate fluid in the lower eyelids, has developed festoons, or has large and/or herniating infraorbital fat pads.
  • Lower lid retraction, significant prominent eyes, or severe negative facial vector.
  • Dark circles under the eyes due to pigmentation changes and not from infraorbital hollow shadowing.
  • Ectropium, entropion, or trichiasis of the lower eyelid or eye diseases that lead to reddening and tendency of watering of the eye.
  • Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
  • 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.
  • 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 (e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., vitamin E, garlic, gingko), from 10 days before to 3 days after injection.
  • Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety (e.g., increase the risk of AEs).

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): NCT03777917


Contacts
Contact: Public Disclosure Manager 984.222.6045 clinicaltrials@merz.com

Locations
United States, Florida
Center for Sight, Merz Investigational Site #0010414 Recruiting
Sarasota, Florida, United States, 34239
United States, Tennessee
Center for Laser and Facial Surgery, Merz Investigational Site #0010353 Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Merz North America, Inc.
Investigators
Study Director: Merz Medical Expert Merz North America, Inc.

Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT03777917     History of Changes
Other Study ID Numbers: M930121001
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents