Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Last updated on April 2022Recruitment
- 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
- SMF rating of 2 or 3 by clinician and patient
- Dissatisfaction with the submental area expressed by participants
- Signed informed consent (ICF)
- Acceptable volume of submental fat graded by clinician
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
- Absence of clinically significant health problems
- 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
- 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)
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
- SMF rating of 2 or 3 by clinician and patient
- Dissatisfaction with the submental area expressed by participants
- Signed informed consent (ICF)
- Acceptable volume of submental fat graded by clinician
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
- Absence of clinically significant health problems
- 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
- 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)
Tracking Information
- NCT #
- NCT02123134
- Collaborators
- Not Provided
- Investigators
- Study Director: Frederick Beddingfield, III, MD, PhD Sponsor GmbH
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