Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Convexity of Submental Fat, Safety, Efficacy

In brief

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.

Key facts

Study ID

NCT02123134

Run by

Kythera Biopharmaceuticals

People needed

55

Starts

2014-04-01

Expected to finish

2015-09-01

Last updated by the study team

2020-02-17

Who can join

Age: 65 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Metairie, Louisiana, United States
• Study site — White Plains, New York, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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