Clinical trial NCT02159729: Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Submental Fat
Healthy
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
measure: 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
timeFrame: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
measure: 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
timeFrame: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
measure: 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
timeFrame: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Beverly Hills
country: United States
facility: Clinical Testing Center Beverly Hills
state: California
city: Beverly Hills
country: United States
facility: Mokusiga, Inc
state: California
city: San Francisco
country: United States
facility: Plastic & Reconstructive Surgery
state: California
city: Naperville
country: United States
facility: Dermatology Institute of DuPage Medical Group in Naperville
state: Illinois
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Body Aesthetic Research Center
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Sydney
country: Australia
facility: Mei-Heng Tan
state: New South Wales
city: Benowa
country: Australia
facility: Skin Centre, AHC House
state: Queensland
city: Carina Heights
country: Australia
facility: Southeast Dermatology Belmont Specialist Centre
state: Queensland
city: South Yarra
country: Australia
facility: T/AS Dermatology Institute of Victoria
state: Victoria
city: Niagara Falls
country: Canada
facility: Niagara Falls Dermatology & Skin Care
state: Ontario
city: Oakville
country: Canada
facility: Institute of Cosmetic & Laser Surgery
state: Ontario
city: Toronto
country: Canada
facility: Toronto Cosmetic Skin Surgery Centre
state: Ontario
city: Toronto
country: Canada
facility: Cosmetic Dermatology on Bloor
state: Ontario
city: Salford
country: United Kingdom
facility: The Dermatology Centre
state: Manchester
city: London
country: United Kingdom
facility: Cranley Clinic, Harcout House
Study officials:
affiliation: Sponsor GmbH
name: Frederick Beddingfield, III, MD, PhD
role: STUDY_DIRECTOR
References: