Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01294644
First received: February 10, 2011
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

To evaluate the safety 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 3

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: Phase 3, 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

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

    A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last 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.


  • Percentage of Participants With a Subject Self Rating Scale (SSRS) Response [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

    A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.

    The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.



Secondary Outcome Measures:
  • Percentage of Participants With a CR-SMFRS 2-grade Response [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

    A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last 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.


  • Change From Baseline in CR-SMFRS Score [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ 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 SSRS Scores [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

    The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.

    A positive change from Baseline indicates improvement.


  • Change From Baseline in Submental Fat Thickness [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]
    Submental thickness was measured using caliper devices.

  • Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]
    The PR-SMFRS is based on the participant's response to the question "How much fat do you currently have under your chin?" 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. Improvement is defined as any decrease in score and worsened as any increase in score.

  • Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]
    The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.

  • Change From Baseline in Self-rating of Attractiveness [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

    Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:

    How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?" Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.

    A positive change from Baseline indicates improvement.


  • Change From Baseline in Derriford Appearance Scale 24 (DAS24) [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Image Quality of Life Inventory (BIQLI) [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (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 4 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 4 treatments.
Drug: Deoxycholic acid injection
Other Name: ATX-101
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 4 treatments.
Drug: Deoxycholic acid injection
Other Name: ATX-101

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
  2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
  3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
  4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
  5. Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
  6. Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
  7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
  2. Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
  3. Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
  4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
  5. Body mass index (BMI) greater than 30.
  6. Currently on or considering starting a weight reduction regimen.
  7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
  8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
  9. History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
  10. Previous randomization into this study or previous treatment with ATX-101.
  11. Treatment with an investigational device or agent within 30 days of randomization.
  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: NCT01294644

Locations
Belgium
Investigational Site
Geel, Belgium, 2440
Investigational Site
Genk, Belgium, 3600
France
Investigational Site
Besançon, France, 25030
Investigational Site
Nice, France, 06000
Investigational Site
Paris, France, 75007
Investigational Site
Paris, France, 75116
Investigational Site
Rouen, France, 76100
Germany
Investigational Site
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
Investigational Site
Berlin, Germany, 13705
Investigational Site
Berlin, Germany, 10827
Investigational Site
Bochum, Germany, 44791
Investigational Site
Dresden, Germany, 01097
Investigational Site
Dresden, Germany, 01067
Investigational Site
Erlangen, Germany, 91054
Investigational Site
Freiburg, Germany, 79104
Investigational Site
Hamburg, Germany, 20146
Investigational Site
Hamburg, Germany, 20354
Investigational Site
Kassel, Germany, 34121
Investigational Site
Lübeck, Germany, 23538
Investigational Site
Mahlow, Germany, 15831
Investigational Site
Monchengladbach, Germany, 41236
Investigational Site
Münster, Germany, 48159
Investigational Site
Regensburg, Germany, 93042
Italy
Investigational Site
Roma, Italy, 00185
Spain
Investigational Site
Madrid, Spain, 28043
United Kingdom
Investigational Site
Birmingham, United Kingdom, B74 2UG
Investigational Site
Cardiff, United Kingdom, CF10 2GF
Investigational Site
London, United Kingdom, W1G 8SF
Investigational Site
Loughborough, United Kingdom, LE11 1TZ
Sponsors and Collaborators
Kythera Biopharmaceuticals
Bayer
Investigators
Study Director: Frederick Beddingfield, MD, PhD Kythera Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01294644     History of Changes
Other Study ID Numbers: ATX-101-10-17, 2010-020691-28
Study First Received: February 10, 2011
Results First Received: May 28, 2015
Last Updated: May 28, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 07, 2015