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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
Assessment method [1] 0 0
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
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
Assessment method [2] 0 0
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
Assessment method [1] 0 0
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
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
Assessment method [2] 0 0
The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.
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
Assessment method [3] 0 0
Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.
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
Assessment method [4] 0 0
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.
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
Assessment method [5] 0 0
The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.
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
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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