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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00618618




Registration number
NCT00618618
Ethics application status
Date submitted
8/02/2008
Date registered
20/02/2008
Date last updated
14/07/2015

Titles & IDs
Public title
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Scientific title
Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
Secondary ID [1] 0 0
2007-006303-21
Secondary ID [2] 0 0
ATX-101-07-07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate or Severe Submental Fullness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deoxycholic Acid Injection

Experimental: Deoxycholic Acid Injection 0.2 mL/0.7 cm - Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo comparator: Placebo 0.2 mL/0.7 cm - Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic Acid Injection 0.2 mL/1.0 cm - Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo comparator: Placebo 0.2 mL/1.0 cm - Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic Acid Injection 0.4 mL/1.0 cm - Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo comparator: Placebo 0.4 mL/1.0 cm - Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.


Treatment: Drugs: Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Primary outcome [2] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Timepoint [2] 0 0
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Secondary outcome [1] 0 0
Change From Baseline in Submental Fat (SMF) Rating Scale Score
Timepoint [1] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [2] 0 0
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
Timepoint [2] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [3] 0 0
Percentage of Participants With a Response in the Subject Global Improvement Rating
Timepoint [3] 0 0
4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [4] 0 0
Percentage of Participants With an SMF Response
Timepoint [4] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [5] 0 0
Change From Baseline in Skin Laxity Rating
Timepoint [5] 0 0
Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Secondary outcome [6] 0 0
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score
Timepoint [6] 0 0
Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Secondary outcome [7] 0 0
Change From Baseline in the Cervicomental Angle
Timepoint [7] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [8] 0 0
Visual Analogue Scale Pain Intensity Rating
Timepoint [8] 0 0
Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12

Eligibility
Key inclusion criteria
* Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
* Good general health
* Signed informed consent
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of any treatment in the neck or chin area
* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site - Toorak
Recruitment hospital [2] 0 0
Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
3142 - Toorak
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frederick Beddingfield, III, M.D., Ph.D.
Address 0 0
Kythera Biopharmaceuticals, Inc.
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.