Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Moderate or Severe Submental Fullness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032889
• Other study ID #: ATX-101-09-15
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2009
• Last updated: May 28, 2015
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate or Severe Submental Fullness

Intervention

Drug:
• Deoxycholic acid injection

• Placebo
Phosphate buffered saline placebo for injection

Locations

Country	Name	City	State
United States	Investigational Site	Beverly Hills	California
United States	Investigational Site	Beverly Hills	California
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Chestnut Hill	Massachusetts
United States	Investigational Site	Fridley	Minnesota
United States	Investigational Site	Naperville	Illinois
United States	Investigational Site	Omaha	Nebraska
United States	Investigational Site	Plano	Texas
United States	Investigational Site	San Francisco	California
United States	Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores	The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)	No
Primary	Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)	The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)	No
Primary	Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)	The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)	No
Secondary	Change From Baseline in Submental Fat Volume	Submental fat volume was measured by magnetic resonance imaging (MRI).	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)	No
Secondary	Change From Baseline in Submental Fat Thickness	Submental fat thickness was measured by magnetic resonance imaging (MRI).	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)	No