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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: May 30, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Healthy
Submental Fat Reduction
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 as assessed by adverse event reports [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Safety of ATX-101 as assessed by physical evaluations [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Safety assessments with Laboratory Measurements [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy assessments using patient reported scales [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Efficacy assessments using a clinician rating scale [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Efficacy assessments using standardized photography [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Efficacy assessments using a submental skin laxity grade scale [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Efficacy assessments on submental fat using calipers [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Long term safety as assessed by adverse event reports [ Time Frame: up to 12 months post treatment ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATX-101 (2 mg/cm2) 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
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: 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
Ava Shamban
Santa Monica, California, United States, 90404
Steven Teitlebaum
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
Neil Sadick
New York, New York, United States, 10075
Roy Geronemus, MD
New York, New York, United States, 10016
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: Frederick Beddingfield, III, M.D., PhD 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: May 30, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014