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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kythera Biopharmaceuticals
• Treatments: Deoxycholic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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