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

Phase 2

Completed

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

• 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2020-01
• Results First Submitted: 2020-02-04
• Results First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Results First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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 & 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.

Trial Locations

Locations (20)

Total Skin & Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Clinical Testing Center Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Mokusiga, Inc; 🇺🇸 Beverly Hills, California, United States

Plastic & Reconstructive Surgery; 🇺🇸 San Francisco, California, United States

Dermatology Institute of DuPage Medical Group in Naperville; 🇺🇸 Naperville, Illinois, United States

Skin Care Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, 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

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