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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00618722




Registration number
NCT00618722
Ethics application status
Date submitted
8/02/2008
Date registered
20/02/2008
Date last updated
14/07/2015

Titles & IDs
Public title
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Scientific title
Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area
Secondary ID [1] 0 0
2007-000146-13
Secondary ID [2] 0 0
ATX-101-06-03
Universal Trial Number (UTN)
Trial acronym
ATX-101
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
Experimental: Deoxycholic Acid Injection 1 mg/cm² - Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic acid Injection 2 mg/cm² - Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic acid Injection 4 mg/cm² - Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo comparator: Placebo - Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
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
Change From Baseline in Skin Laxity Rating
Timepoint [4] 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 [5] 0 0
Change From Baseline in the Cervicomental Angle
Timepoint [5] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)

Eligibility
Key inclusion criteria
* Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the 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 1
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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site - Carina Heights
Recruitment hospital [2] 0 0
Investigational Site - Gold Coast
Recruitment hospital [3] 0 0
Investigational Site - Toorak
Recruitment postcode(s) [1] 0 0
- Carina Heights
Recruitment postcode(s) [2] 0 0
- Gold Coast
Recruitment postcode(s) [3] 0 0
- Toorak
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Niagara Falls
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

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, MD. PhD
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.

Results are available at https://clinicaltrials.gov/study/NCT00618722