Open-Label Study of ATX-101 for the Reduction of Localized Subcutaneous Fat in the Submental Area

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01426373
First received: August 26, 2011
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

This is an open-label study evaluating the safety of ATX-101 in the reduction of submental fat.


Condition Intervention Phase
Healthy
Drug: ATX-101
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label Study of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Safety of ATX-101 with subcutaneous injections in the submental area as assessed by adverse event reports, clinical evalution of the submental area, physical examinations and laboratory test results. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the effects of ATX-101 in the submental area using a Submental Fat Rating Scale and a Subject Self Rating Scale, as well determining the improvement in other measures of submental fat and its impact using various Subject assessments. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
    Assessments include a submental fat impact scale, a self-rating scale, self-ratings of attractivenes, laxity grade, Subject global questions, calipers, photography.


Enrollment: 165
Study Start Date: July 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ATX-101
    ATX-101 2mg/cm2
Detailed Description:

To evaluate the safety of ATX-101 subcutaneous injections in the submental area.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1 (within 28 days before the subject's first dosing session).
  • Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1 (within 28 days before the subject's first dosing session).
  • Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (Visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) (serum) test result within 28 days before Visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study.
  • A normal result on coagulation tests (PT, PTT) obtained within 28 days before subject's first dosing session.
  • History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session.
  • Expected to understand and comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
  • Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before subject's first dosing session for which the investigator identifies no clinically significant abnormality.
  • Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  • History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).
  • History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
  • A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.
  • Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
  • Body mass index of ≥40 as determined on Visit 1 (Week 0)
  • History or current symptoms of dysphagia.
  • Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.
  • Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session.
  • History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, novocaine).
  • Previous treatment in this study or previous participation in a Kythera-sponsored ATX 101 trial.
  • Treatment with an investigational device or agent within 30 days before the subject's first treatment session.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426373

Locations
United States, California
Mark Rubin
Beverly Hills, California, United States, 90212
Mitchel Goldman
LaJolla, California, United States, 92121
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Jeffrey Klein
San Juan Capistrano, California, United States, 92675
Steven Teitlebaum
Santa Monica, California, United States, 90404
Ava Shamban
Santa Monica, California, United States, 90404
United States, Florida
Susan Weinkle
Bradenton, Florida, United States, 34209
Palm Beach Cosmetic
West Palm Beach, Florida, United States, 33401
United States, Illinois
Steven Dayan
Chicago, Illinois, United States, 60611
United States, Louisiana
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, United States, 70124
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Nevada
Linda Woodson
Las Vegas, Nevada, United States, 89128
United States, New Jersey
David Goldberg, MD
Hillsborough, New Jersey, United States, 08844
United States, New York
Macrene Alexiades-Armenakas
New York, New York, United States, 10028
Roy Geronemus, MD
New York, New York, United States, 10016
Neil Sadick
New York, New York, United States, 10075
United States, North Carolina
Sue Ellen Cox
Chapel Hill, North Carolina, United States, 27517
United States, Pennsylvania
Richard Fried
Yardley, Pennsylvania, United States, 19067
United States, Tennessee
Michael Gold
Nashville, Tennessee, United States, 37215
United States, Texas
Suzanne Bruce
Houston, Texas, United States, 77056
Jeffrey Adelglass
Plano, Texas, United States, 75093
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D. Kythera Biopharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01426373     History of Changes
Other Study ID Numbers: ATX-101-11-26
Study First Received: August 26, 2011
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Kythera Biopharmaceuticals:
Healthy subjects

ClinicalTrials.gov processed this record on April 17, 2014