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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163902
• Other study ID #: ATX-101-13-35
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Est. completion date: August 2016

Study information

• Verified date: January 2020
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

No study medication is administered in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Submental Fat

Intervention

Drug:
• ATX-101
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
• Placebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Locations

Country	Name	City	State
Canada	Carruthers Dermatology Centre Inc.	Vancouver
Canada	Shannon Humphrey, MD	Vancouver
United States	Altman Dermatology Associates	Arlington Hts	Illinois
United States	DeNova Research	Chicago	Illinois
United States	Dermatology Research Institute	Coral Gables	Florida
United States	Stephan Baker MD PA	Coral Gables	Florida
United States	AboutSkin Dermatology and DermSurgery, PC	Englewood	Colorado
United States	Callender Center for Clinical Research	Glendale	Maryland
United States	Baumann Cosmetic and Research Center	Miami	Florida
United States	DuPage Medical Group, Dermatology Institute	Naperville	Illinois
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Research Across America	Plano	Texas
United States	Aesthetics, Skin Care, Dermatologic Surgery	Rockville	Maryland
United States	Dermatology Cosmetic Laser Medical Associates of La Jolla	San Diego	California
United States	Kenneth R. Beer, MD, PA	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary	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	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	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.
Secondary	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	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.	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary	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	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.	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary	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	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.	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary	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	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.	From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment