Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2007-000146-13
Query!
Secondary ID [2]
0
0
ATX-101-06-03
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ATX-101
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Moderate or Severe Submental Fullness
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Deoxycholic Acid Injection
Treatment: Drugs - Placebo
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.
Treatment: Drugs: Deoxycholic Acid Injection
Treatment: Drugs: Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events
Query!
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
Query!
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).
Query!
Primary outcome [2]
0
0
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Query!
Assessment method [2]
0
0
Query!
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).
Query!
Secondary outcome [1]
0
0
Change From Baseline in Submental Fat (SMF) Rating Scale Score
Query!
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.
Query!
Timepoint [1]
0
0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Query!
Secondary outcome [2]
0
0
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
Query!
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.
Query!
Timepoint [2]
0
0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With a Response in the Subject Global Improvement Rating
Query!
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.
Query!
Timepoint [3]
0
0
4 weeks after last treatment (up to 16 weeks after first dose)
Query!
Secondary outcome [4]
0
0
Change From Baseline in Skin Laxity Rating
Query!
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.
Query!
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)
Query!
Secondary outcome [5]
0
0
Change From Baseline in the Cervicomental Angle
Query!
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.
Query!
Timepoint [5]
0
0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Query!
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
Query!
Minimum age
25
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
85
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site - Carina Heights
Query!
Recruitment hospital [2]
0
0
Investigational Site - Gold Coast
Query!
Recruitment hospital [3]
0
0
Investigational Site - Toorak
Query!
Recruitment postcode(s) [1]
0
0
- Carina Heights
Query!
Recruitment postcode(s) [2]
0
0
- Gold Coast
Query!
Recruitment postcode(s) [3]
0
0
- Toorak
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Ontario
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Niagara Falls
Query!
Country [3]
0
0
United Kingdom
Query!
State/province [3]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Kythera Biopharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To evaluate the safety and potential efficacy of deoxycholic acid injection compared to
placebo for the reduction of submental fat (fat below the chin).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00618722
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Frederick Beddingfield, MD. PhD
Query!
Address
0
0
Kythera Biopharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00618722
Download to PDF