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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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|
- 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.
- 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 ]
- 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 ]
- 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.
- 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.
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
|Contact: Public Disclosure Managerfirstname.lastname@example.org|
|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|
|Study Director:||Merz Medical Expert||Merz North America, Inc.|