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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01032889
First received: December 10, 2009
Last updated: May 28, 2015
Last verified: May 2015
  Purpose
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Condition Intervention Phase
Moderate or Severe Submental Fullness
Drug: Deoxycholic acid injection
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Submental Fat Volume [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ] [ Designated as safety issue: No ]
    Submental fat volume was measured by magnetic resonance imaging (MRI).

  • Change From Baseline in Submental Fat Thickness [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ] [ Designated as safety issue: No ]
    Submental fat thickness was measured by magnetic resonance imaging (MRI).


Enrollment: 129
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Placebo
Phosphate buffered saline placebo for injection
Experimental: Deoxycholic acid Injection 1 mg/cm²
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Deoxycholic acid injection
Other Names:
  • ATX-101
  • Kybella
Experimental: Deoxycholic acid Injection 2 mg/cm²
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Drug: Deoxycholic acid injection
Other Names:
  • ATX-101
  • Kybella

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032889

Locations
United States, Alabama
Investigational Site
Birmingham, Alabama, United States, 35205
United States, California
Investigational Site
Beverly Hills, California, United States, 90210
Investigational Site
Beverly Hills, California, United States, 90212
Investigational Site
San Francisco, California, United States, 94115
United States, Illinois
Investigational Site
Naperville, Illinois, United States, 60563
United States, Massachusetts
Investigational Site
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Investigational Site
Fridley, Minnesota, United States, 55432
United States, Missouri
Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Investigational Site
Omaha, Nebraska, United States, 68144
United States, Texas
Investigational Site
Plano, Texas, United States, 75093
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Frederick Beddingfield, MD, PhD Kythera Biopharmaceuticals, Inc.
  More Information

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01032889     History of Changes
Other Study ID Numbers: ATX-101-09-15 
Study First Received: December 10, 2009
Results First Received: May 28, 2015
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on December 07, 2016