Clinical trial NCT02163902: Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Submental Fat
Healthy
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 224
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: The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.

Detailed description: No study medication is administered in this study.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary outcomes:
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
measure: 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
timeFrame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla
state: California
city: Englewood
country: United States
facility: AboutSkin Dermatology and DermSurgery, PC
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
city: Coral Gables
country: United States
facility: Stephan Baker MD PA
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, MD, PA
state: Florida
city: Arlington Hts
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Naperville
country: United States
facility: DuPage Medical Group, Dermatology Institute
state: Illinois
city: Glendale
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Rockville
country: United States
facility: Aesthetics, Skin Care, Dermatologic Surgery
state: Maryland
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Vancouver
country: Canada
facility: Shannon Humphrey, MD
city: Vancouver
country: Canada
facility: Carruthers Dermatology Centre Inc.
Study officials:
affiliation: Sponsor GmbH
name: Frederick Beddingfield, III, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B. Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials. Aesthet Surg J. 2021 Oct 15;41(11):NP1532-NP1539. doi: 10.1093/asj/sjab100.