Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

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

Exclusion Criteria

No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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
...
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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
Body mass index of ≥40.0 kg/m^2

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

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

Exclusion Criteria

No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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
...
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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
Body mass index of ≥40.0 kg/m^2

Tracking Information

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