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:
NCT01305577
First received: February 10, 2011
Last updated: June 17, 2015
Last verified: June 2015

February 10, 2011
June 17, 2015
December 2010
January 2012   (final data collection date for primary outcome measure)
  • 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.

Submental Fat Rating Scale [ Time Frame: 12 weeks after last treatment ] [ Designated as safety issue: No ]
Submental Fat Rating Scale - A clinician's assessment of the amount of submental fat and a Subject Self Rating Scale
Complete list of historical versions of study NCT01305577 on ClinicalTrials.gov Archive Site
  • 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 Scores [ 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 ]
  • Subject Reported Outcome Measures [ Time Frame: 12 weeks after last treatment ] [ Designated as safety issue: No ]
    Subject-Reported Outcome Measures will include: PR-SMFRS, PR-SMFIS, Self-Ratings of Attractiveness, Derriford Appearance Scale (DAS), Body Image Quality of Life Inventory (BIQLI), Other Subject-Reported Questions, Subject-Reported Global Questions and Post-treatment questions. Subjects must complete the subject-reported outcome measures at the research facility at scheduled visits.
  • Measure of SMF thickness using Calipers [ Time Frame: 12 weeks after last treatment ] [ Designated as safety issue: No ]
    Caliper measurements will be made at Visits 3, 4, 5, 6, and 7. The number of millimeters (mm) displayed on the caliper device will be recorded. Measurements will be made using calipers provided by Kythera and according to instructions provided by Kythera.
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
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

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Moderate or Severe Submental Fullness
  • Drug: Deoxycholic acid injection
    Other Name: ATX-101
  • Drug: Placebo
    Phosphate buffered saline placebo for injection
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Deoxycholic acid injection
  • 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.
    Intervention: Drug: Deoxycholic acid injection
McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Spain,   United Kingdom
Italy
 
NCT01305577
ATX-101-10-16, 2010-020690-17
No
Kythera Biopharmaceuticals
Kythera Biopharmaceuticals
Bayer
Study Director: Frederick Beddingfield, MD, PhD Kythera Biopharmaceuticals, Inc.
Kythera Biopharmaceuticals
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP