Clinical trial NCT02035267: Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
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 With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4
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: 2014-01-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
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 in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, 18 to 65 years old
* Stable Body weight
* Body Mass Index (BMI) of ≤40.0 kg/m\^2
* Acceptable volume of submental fat graded by clinician
* Dissatisfaction with the submental area expressed by the subject
* Signed informed consent form (ICF)
* SMF ratings of 1 or 4

Exclusion Criteria:

* No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
* Presence of clinically significant health problems
* History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
* Body mass index ≤40 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 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 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: Newport Beach
country: United States
state: California
city: San Francisco
country: United States
state: California
city: West Hollywood
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Glenn Dale
country: United States
state: Maryland
city: Chestnut Hill
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
Study officials:
affiliation: Sponsor GmbH
name: Frederick Beddingfield, III, MD, PhD
role: STUDY_DIRECTOR
References: