Clinical trial NCT02123134: Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Official title: A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Convexity of Submental Fat
Safety
Efficacy
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-04-25
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
timeFrame: Baseline and up to Week 32 (12 weeks after last treatment)
measure: Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
timeFrame: Baseline and up to Week 32 (12 weeks after last treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Metairie
country: United States
state: Louisiana
city: White Plains
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Sponsor GmbH
name: Frederick Beddingfield, III, MD, PhD
role: STUDY_DIRECTOR
References: