Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criterias

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

Exclusion Criterias

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

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 Criterias

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

Exclusion Criterias

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

Locations

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

Tracking Information

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