Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

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

Exclusion Criteria

Absence of clinically significant health problems
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
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
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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

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

Exclusion Criteria

Absence of clinically significant health problems
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
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
No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
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