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Completed

NCT Number: NCT01032889

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

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

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Key information

Conditions

Moderate or Severe Submental Fullness Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deoxycholic acid Injection

Drug

Other names: ATX-101, Kybella

Placebo

Drug

Phosphate buffered saline placebo for injection

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Kythera Biopharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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