NCT02163902

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2013

Typical duration for phase_3

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

June 12, 2014

Results QC Date

February 4, 2020

Last Update Submit

February 4, 2020

Conditions

Submental FatHealthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.

  • 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

    From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

  • 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

    From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

  • 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

    From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

  • 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

    From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

Study Arms (2)

ATX-101

EXPERIMENTAL

Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.

Drug: ATX-101

Placebo

PLACEBO COMPARATOR

Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.

Drug: Placebo

Interventions

ATX-101DRUG

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

ATX-101
PlaceboDRUG

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
  • Willingness to comply with the schedule and procedures of this study.
  • Signed informed consent form (ICF).

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Dermatology Cosmetic Laser Medical Associates of La Jolla

San Diego, California, 92121, United States

Location

AboutSkin Dermatology and DermSurgery, PC

Englewood, Colorado, 80113, United States

Location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

Stephan Baker MD PA

Coral Gables, Florida, 33146, United States

Location

Baumann Cosmetic and Research Center

Miami, Florida, 33137, United States

Location

Kenneth R. Beer, MD, PA

West Palm Beach, Florida, 33401, United States

Location

Altman Dermatology Associates

Arlington Hts, Illinois, 60005, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

DuPage Medical Group, Dermatology Institute

Naperville, Illinois, 60563, United States

Location

Callender Center for Clinical Research

Glendale, Maryland, 20769, United States

Location

Aesthetics, Skin Care, Dermatologic Surgery

Rockville, Maryland, 20850, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Shannon Humphrey, MD

Vancouver, V5Z 4E1, Canada

Location

Carruthers Dermatology Centre Inc.

Vancouver, V5Z4E1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33617632DERIVED

Results Point of Contact

Title
Beta Bowen
Organization
Allergan, Inc
Bowen_Beta@allergan.com
714-246-4446

Study Officials

  • Frederick Beddingfield, III, MD, PhD

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

February 17, 2020

Results First Posted

February 17, 2020

Record last verified: 2020-01

Locations

US(13)CA(2)