Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Study Overview

• Status: Completed
• Conditions: Healthy; Submental Fat
• Intervention / Treatment: Drug: Placebo; Drug: ATX-101 (1 mg/cm^2); Drug: ATX-101 (2 mg/cm^2); Drug: ATX-101 (4 mg/cm^2)

Detailed Description

No study medication was administered in this study.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Mei-Heng Tan
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Skin Centre, AHC House
    • Carina Heights, Queensland, Australia, 4152
      • Southeast Dermatology Belmont Specialist Centre
  • Victoria
    • South Yarra, Victoria, Australia, 3141
      • T/AS Dermatology Institute of Victoria
• Canada
  • Ontario
    • Niagara Falls, Ontario, Canada, L2E 7H1
      • Niagara Falls Dermatology & Skin Care
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic & Laser Surgery
    • Toronto, Ontario, Canada, M4V 1R1
      • Toronto Cosmetic Skin Surgery Centre
    • Toronto, Ontario, Canada, M5S 3B4
      • Cosmetic Dermatology on Bloor
• United Kingdom
  • London, United Kingdom, W1G OPN
    • Cranley Clinic, Harcout House
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • The Dermatology Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin & Beauty Dermatology Center
  • California
    • Beverly Hills, California, United States, 90210
      • Clinical Testing Center Beverly Hills
    • Beverly Hills, California, United States, 90212
      • Mokusiga, Inc
    • San Francisco, California, United States, 94115
      • Plastic & Reconstructive Surgery
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Dermatology Institute of DuPage Medical Group in Naperville
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skin Care Physicians
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Body Aesthetic Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • Texas
    • Plano, Texas, United States, 75093
      • Research Across America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15)
• Signed informed consent
• Willingness to comply with schedule and procedures of the study

Exclusion Criteria:

• Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants treated with placebo in previous ATX-101 studies	Drug: Placebo; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Experimental: ATX-101 (1 mg/cm^2); Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies	Drug: ATX-101 (1 mg/cm^2); Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Experimental: ATX-101 (2 mg/cm^2); Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies	Drug: ATX-101 (2 mg/cm^2); Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Experimental: ATX-101 (4 mg/cm^2); Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies	Drug: ATX-101 (4 mg/cm^2); Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits	The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.	Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits	The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.	Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits	The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.	Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits	The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.	Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ATX-101-08-12