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

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ClinicalTrials.gov Identifier: NCT01032889
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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 :
  1. Change From Baseline in Submental Fat Volume [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ]
    Submental fat volume was measured by magnetic resonance imaging (MRI).

  2. Change From Baseline in Submental Fat Thickness [ Time Frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) ]
    Submental fat thickness was measured by magnetic resonance imaging (MRI).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01032889     History of Changes
Other Study ID Numbers: ATX-101-09-15
First Posted: December 16, 2009    Key Record Dates
Results First Posted: June 15, 2015
Last Update Posted: June 15, 2015
Last Verified: May 2015

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