Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
- Conditions
- Submental FatHealthy
- Interventions
- Registration Number
- NCT02159729
- Lead Sponsor
- Kythera Biopharmaceuticals
- Brief Summary
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
- Detailed Description
No study medication was administered in this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- 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
- Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants treated with placebo in previous ATX-101 studies ATX-101 (1 mg/cm^2) ATX-101 (1 mg/cm^2) Participants treated with ATX-101 (1 mg/cm\^2) in previous phase 2 studies ATX-101 (2 mg/cm^2) ATX-101 (2 mg/cm^2) Participants treated with ATX-101 (2 mg/cm\^2) in previous phase 2 studies ATX-101 (4 mg/cm^2) ATX-101 (4 mg/cm^2) Participants treated with ATX-101 (4 mg/cm\^2) in previous phase 2 studies
- Primary Outcome Measures
Name Time Method 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 Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) 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.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 Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) 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.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 Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) 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.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 Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Dermatology Institute of DuPage Medical Group in Naperville
🇺🇸Naperville, Illinois, United States
Clinical Testing Center Beverly Hills
🇺🇸Beverly Hills, California, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
The Dermatology Centre
🇬🇧Salford, Manchester, United Kingdom
Total Skin & Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States
Mokusiga, Inc
🇺🇸Beverly Hills, California, United States
Plastic & Reconstructive Surgery
🇺🇸San Francisco, California, United States
Skin Care Physicians
🇺🇸Chestnut Hill, Massachusetts, United States
Body Aesthetic Research Center
🇺🇸Saint Louis, Missouri, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Research Across America
🇺🇸Plano, Texas, United States
Skin Centre, AHC House
🇦🇺Benowa, Queensland, Australia
Mei-Heng Tan
🇦🇺Sydney, New South Wales, Australia
T/AS Dermatology Institute of Victoria
🇦🇺South Yarra, Victoria, Australia
Institute of Cosmetic & Laser Surgery
🇨🇦Oakville, Ontario, Canada
Niagara Falls Dermatology & Skin Care
🇨🇦Niagara Falls, Ontario, Canada
Toronto Cosmetic Skin Surgery Centre
🇨🇦Toronto, Ontario, Canada
Cosmetic Dermatology on Bloor
🇨🇦Toronto, Ontario, Canada
Cranley Clinic, Harcout House
🇬🇧London, United Kingdom
Southeast Dermatology Belmont Specialist Centre
🇦🇺Carina Heights, Queensland, Australia