Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

SMF rating of 2 or 3 by clinician and patient
Dissatisfaction with the submental area expressed by participants
Males and females, 65 to 75 years of age
...
SMF rating of 2 or 3 by clinician and patient
Dissatisfaction with the submental area expressed by participants
Males and females, 65 to 75 years of age
Acceptable volume of submental fat graded by clinician
BMI of ≤40.0 kg/m^2
Stable Body Weight
Signed informed consent (ICF)

Exclusion Criteria

History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
Body mass index of ≥40.0 kg/m^2
...
History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
Body mass index of ≥40.0 kg/m^2
Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
Absence of clinically significant health problems

Summary

Conditions
  • Efficacy
  • Moderate to Severe Convexity of Submental Fat
  • Safety
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 75 years
Gender
Both males and females

Inclusion Criteria

SMF rating of 2 or 3 by clinician and patient
Dissatisfaction with the submental area expressed by participants
Males and females, 65 to 75 years of age
...
SMF rating of 2 or 3 by clinician and patient
Dissatisfaction with the submental area expressed by participants
Males and females, 65 to 75 years of age
Acceptable volume of submental fat graded by clinician
BMI of ≤40.0 kg/m^2
Stable Body Weight
Signed informed consent (ICF)

Exclusion Criteria

History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
Body mass index of ≥40.0 kg/m^2
...
History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
Body mass index of ≥40.0 kg/m^2
Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
Absence of clinically significant health problems

Locations

White Plains, New York, 10604
Metairie, Louisiana, 70006
Los Angeles, California, 90036
Cincinnati, Ohio, 45255
Bradenton, Florida, 34209
...
White Plains, New York, 10604
Metairie, Louisiana, 70006
Los Angeles, California, 90036
Cincinnati, Ohio, 45255
Bradenton, Florida, 34209
Birmingham, Alabama, 35205

Tracking Information

NCT #
NCT02123134
Collaborators
Not Provided
Investigators
Study Director: Frederick Beddingfield, III, MD, PhD Sponsor GmbH