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

Kythera Biopharmaceuticals55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Moderate to Severe Convexity of Submental Fat Safety Efficacy

Interventions

ATX-101DRUG

Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

PlaceboDRUG

Phosphate buffered saline placebo for injection

Eligibility

Sex: ALLMin age: 65 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Bradenton, Florida, United States

Unnamed facility

Metairie, Louisiana, United States

Outcomes

Primary Outcomes

Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

Time frame: Baseline and up to Week 32 (12 weeks after last treatment)

Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

Time frame: Baseline and up to Week 32 (12 weeks after last treatment)

Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

Time frame: Baseline and up to Week 32 (12 weeks after last treatment)

Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

Data from ClinicalTrials.gov

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