Phase 3 N=55 Randomized Double-blind Treatment

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

Moderate to Severe Convexity of Submental Fat · Safety · Efficacy

Bottom Line

View on ClinicalTrials.gov: NCT02123134 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Feb 2020

Primary outcome: Primary: 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 — 68.0; 25.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ATX-101 (Drug); Placebo (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Kythera Biopharmaceuticals
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	68.0; 25.0	—
PRIMARY 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	8.0; 4.2	—
PRIMARY 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)	84.0; 41.7	—
PRIMARY 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)	60.0; 12.5	—
PRIMARY 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)	80.0; 45.8	—
PRIMARY Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)	20.0; 20.8	—
PRIMARY Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)	-0.5; -0.1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02123134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.