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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159729
• Other study ID #: ATX-101-08-12
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: December 2015

Study information

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

Clinical Trial 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)

Description:

No study medication was administered in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Submental Fat

Intervention

Drug:
• Placebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
• ATX-101 (1 mg/cm^2)
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
• ATX-101 (2 mg/cm^2)
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
• ATX-101 (4 mg/cm^2)
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

Locations

Country	Name	City	State
Australia	Skin Centre, AHC House	Benowa	Queensland
Australia	Southeast Dermatology Belmont Specialist Centre	Carina Heights	Queensland
Australia	T/AS Dermatology Institute of Victoria	South Yarra	Victoria
Australia	Mei-Heng Tan	Sydney	New South Wales
Canada	Niagara Falls Dermatology & Skin Care	Niagara Falls	Ontario
Canada	Institute of Cosmetic & Laser Surgery	Oakville	Ontario
Canada	Cosmetic Dermatology on Bloor	Toronto	Ontario
Canada	Toronto Cosmetic Skin Surgery Centre	Toronto	Ontario
United Kingdom	Cranley Clinic, Harcout House	London
United Kingdom	The Dermatology Centre	Salford	Manchester
United States	Clinical Testing Center Beverly Hills	Beverly Hills	California
United States	Mokusiga, Inc	Beverly Hills	California
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	Skin Care Physicians	Chestnut Hill	Massachusetts
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Institute of DuPage Medical Group in Naperville	Naperville	Illinois
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Research Across America	Plano	Texas
United States	Body Aesthetic Research Center	Saint Louis	Missouri
United States	Plastic & Reconstructive Surgery	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)