Clinical trial NCT01032889: Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 129
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: Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).


Eligibility criteria: Inclusion Criteria:

* Moderate or severe submental fat
* Dissatisfaction with submental area
* History of stable body weight
* Signed informed consent

Exclusion Criteria:

* Any medical or other condition that would affect subject safety or evaluation of efficacy
* Previous intervention in the submental area

Primary outcomes:
measure: Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
measure: Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
measure: Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Secondary outcomes:
measure: Change From Baseline in Submental Fat Volume
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
measure: Change From Baseline in Submental Fat Thickness
timeFrame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Naperville
country: United States
facility: Investigational Site
state: Illinois
city: Chestnut Hill
country: United States
facility: Investigational Site
state: Massachusetts
city: Fridley
country: United States
facility: Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: Plano
country: United States
facility: Investigational Site
state: Texas
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Frederick Beddingfield, MD, PhD
role: STUDY_DIRECTOR
References: