Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02159729




Registration number
NCT02159729
Ethics application status
Date submitted
6/06/2014
Date registered
10/06/2014
Date last updated
17/02/2020

Titles & IDs
Public title
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Scientific 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
Secondary ID [1] 0 0
ATX-101-08-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Submental Fat 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ATX-101 (1 mg/cm^2)
Treatment: Drugs - ATX-101 (2 mg/cm^2)
Treatment: Drugs - ATX-101 (4 mg/cm^2)

Placebo Comparator: Placebo - Participants treated with placebo in previous ATX-101 studies

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

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

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


Treatment: Drugs: Placebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

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

Treatment: Drugs: ATX-101 (2 mg/cm^2)
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

Treatment: Drugs: ATX-101 (4 mg/cm^2)
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subjects who have had or are undergoing treatment that may affect the evaluation of
the submental area will be excluded

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Mei-Heng Tan - Sydney
Recruitment hospital [2] 0 0
Skin Centre, AHC House - Benowa
Recruitment hospital [3] 0 0
Southeast Dermatology Belmont Specialist Centre - Carina Heights
Recruitment hospital [4] 0 0
T/AS Dermatology Institute of Victoria - South Yarra
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4152 - Carina Heights
Recruitment postcode(s) [4] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kythera Biopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02159729
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frederick Beddingfield, III, MD, PhD
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02159729