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

NCT02159729 | Completed Phase 2 Results

• 1 other identifier: ATX-101-08-12
• Study Type: interventional
• Target: 205
• Locations: 4 countries
• Sites: 20

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)

Conditions

Submental Fat; Healthy

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants treated with placebo in previous ATX-101 studies

Drug: Placebo

ATX-101 (1 mg/cm^2)

EXPERIMENTAL

Participants treated with ATX-101 (1 mg/cm\^2) in previous phase 2 studies

Drug: ATX-101 (1 mg/cm^2)

ATX-101 (2 mg/cm^2)

EXPERIMENTAL

Participants treated with ATX-101 (2 mg/cm\^2) in previous phase 2 studies

Drug: ATX-101 (2 mg/cm^2)

ATX-101 (4 mg/cm^2)

EXPERIMENTAL

Participants treated with ATX-101 (4 mg/cm\^2) in previous phase 2 studies

Drug: ATX-101 (4 mg/cm^2)

Interventions

Placebo DRUG

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

Placebo

ATX-101 (1 mg/cm^2) DRUG

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

ATX-101 (1 mg/cm^2)

ATX-101 (2 mg/cm^2) DRUG

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

ATX-101 (2 mg/cm^2)

ATX-101 (4 mg/cm^2) DRUG

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

ATX-101 (4 mg/cm^2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (20)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Clinical Testing Center Beverly Hills

Beverly Hills, California, 90210, United States

Location

Mokusiga, Inc

Beverly Hills, California, 90212, United States

Location

Plastic & Reconstructive Surgery

San Francisco, California, 94115, United States

Location

Dermatology Institute of DuPage Medical Group in Naperville

Naperville, Illinois, 60563, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Body Aesthetic Research Center

St Louis, Missouri, 63141, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Mei-Heng Tan

Sydney, New South Wales, 2000, Australia

Location

Skin Centre, AHC House

Benowa, Queensland, 4217, Australia

Location

Southeast Dermatology Belmont Specialist Centre

Carina Heights, Queensland, 4152, Australia

Location

T/AS Dermatology Institute of Victoria

South Yarra, Victoria, 3141, Australia

Location

Niagara Falls Dermatology & Skin Care

Niagara Falls, Ontario, L2E 7H1, Canada

Location

Institute of Cosmetic & Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Toronto Cosmetic Skin Surgery Centre

Toronto, Ontario, M4V 1R1, Canada

Location

Cosmetic Dermatology on Bloor

Toronto, Ontario, M5S 3B4, Canada

Location

The Dermatology Centre

Salford, Manchester, M6 8HD, United Kingdom

Location

Cranley Clinic, Harcout House

London, W1G OPN, United Kingdom

Location

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 2
• 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 6, 2014
• First Posted: June 10, 2014
• Study Start: February 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-01

Locations

AU (4); US (10); CA (4); GB (2)