Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Tracking Information

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