CompletedPhase 3

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

United States55 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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 Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

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

Trial details

NCT IDNCT02123134

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2020-02-03

View on ClinicalTrials.gov More Moderate to Severe Convexity of Submental Fat trials

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 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)

Timeframe: 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)

Timeframe: 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 Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

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