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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163902
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

Brief Summary:
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.

Condition or disease Intervention/treatment Phase
Submental Fat Healthy Drug: ATX-101 Drug: Placebo Phase 3

Detailed Description:
No study medication is administered in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Multicenter, Double-blind, Nontreatment, Long-term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area
Study Start Date : December 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: ATX-101
Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.
Drug: ATX-101
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Placebo Comparator: Placebo
Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.
Drug: Placebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events




Primary Outcome Measures :
  1. Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 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 [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment ]

    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.



Secondary Outcome Measures :
  1. Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment. ]

    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


  2. Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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 [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment ]

    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.


  3. Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment ]

    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.


  4. Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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 [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment ]

    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.


  5. Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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 [ Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
  2. Willingness to comply with the schedule and procedures of this study.
  3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163902


Locations
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United States, California
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, United States, 92121
United States, Colorado
AboutSkin Dermatology and DermSurgery, PC
Englewood, Colorado, United States, 80113
United States, Florida
Dermatology Research Institute
Coral Gables, Florida, United States, 33146
Stephan Baker MD PA
Coral Gables, Florida, United States, 33146
Baumann Cosmetic and Research Center
Miami, Florida, United States, 33137
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, United States, 33401
United States, Illinois
Altman Dermatology Associates
Arlington Hts, Illinois, United States, 60005
DeNova Research
Chicago, Illinois, United States, 60611
DuPage Medical Group, Dermatology Institute
Naperville, Illinois, United States, 60563
United States, Maryland
Callender Center for Clinical Research
Glendale, Maryland, United States, 20769
Aesthetics, Skin Care, Dermatologic Surgery
Rockville, Maryland, United States, 20850
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Research Across America
Plano, Texas, United States, 75093
Canada
Shannon Humphrey, MD
Vancouver, Canada, V5Z 4E1
Carruthers Dermatology Centre Inc.
Vancouver, Canada, V5Z4E1
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
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Study Director: Frederick Beddingfield, III, MD, PhD Sponsor GmbH
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Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02163902    
Other Study ID Numbers: ATX-101-13-35
First Posted: June 16, 2014    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020
Last Verified: January 2020