Evaluation of Safety and Efficacy of ATX-101 in the Reduction of Submental Fat

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305577
First received: February 10, 2011
Last updated: October 11, 2012
Last verified: October 2012

February 10, 2011
October 11, 2012
December 2010
January 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01305577 on ClinicalTrials.gov Archive Site
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 and Self-Ratings of Attractiveness.
  • 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 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

Kythera is evaluating the safety and efficacy of ATX-101 in the reduction of submental fat. ATX-101 is a potential treatment that is a safe and effective nonsurgical approach to reduce localized subcutaneous fat in the submental area in otherwise healthy individuals.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: ATX-101
    ATX-101 1mg/cm2 - Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
    Other Name: sodium deoxycholate injection
  • Drug: ATX-101
    ATX-101 2mg/cm2 - Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
    Other Name: sodium deoxycholate injection
  • Drug: Placebo
    Placebo: Subjects will receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 3 months into the submental area.
    Other Name: Placebo vehicle
  • Placebo Comparator: Placebo
    Placebo vehicle control
    Intervention: Drug: Placebo
  • Experimental: ATX-101 1mg/cm2
    ATX-101 1mg/cm2
    Intervention: Drug: ATX-101
  • Experimental: ATX-101 2 mg/cm2
    ATX-101 2 mg/cm2
    Intervention: Drug: ATX-101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
April 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, Appendix C2).
  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 (Appendix B1).
  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,   Italy,   Spain,   United Kingdom
 
NCT01305577
ATX-101-10-16, 2010-020690-17
No
Daniel R. Lee, M.S., Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc.
Kythera Biopharmaceuticals
Bayer
Study Director: Patricia Walker, MD, PhD Kythera Biopharmaceuticals
Kythera Biopharmaceuticals
October 2012

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