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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
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Trial registered on ANZCTR
Registration number
ACTRN12618001775202
Ethics application status
Not required
Date submitted
3/10/2018
Date registered
29/10/2018
Date last updated
7/11/2018
Date data sharing statement initially provided
29/10/2018
Date results information initially provided
29/10/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Deoxycholic acid as treatment of abdominal fat
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Scientific title
Deoxycholic acid as treatment of abdominal adiposity
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Secondary ID [1]
296235
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
abdominal adiposity
309875
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Condition category
Condition code
Skin
308667
308667
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0
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Other skin conditions
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Diet and Nutrition
308712
308712
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0
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Obesity
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Deoxycholic acid 80mg subcutaneously, 2 doses 8 weeks apart.
The deoxycholic acid will be administered by a Plastic Surgeon to either the right or left side according to patient stratification. He/she will administer the medication to the areas he/she feels would show the best therapeutic response. This process will be repeated in 8 weeks.
4-8 weeks after this, the contralateral side will be treated following the same regimen.
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Intervention code [1]
312562
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Subjective reduction in abdominal fat as reported by patient using a visual analogue scale graded from 0 (no change) to 10 (best possible change)
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Assessment method [1]
307633
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Timepoint [1]
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16-24 weeks from the first treatment administration
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Secondary outcome [1]
352460
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Objective reduction in abdominal fat as assessed by ultrasound
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Assessment method [1]
352460
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Timepoint [1]
352460
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16-24 weeks from the first treatment administration
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Eligibility
Key inclusion criteria
Self-reported abdominal adiposity recalcitrant to diet and exercise
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
<18 years old, inability to give consent, allergy to deoxycholic acid
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/08/2018
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Date of last participant enrolment
Anticipated
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Actual
1/08/2018
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Date of last data collection
Anticipated
1/03/2019
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Actual
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Sample size
Target
1
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Accrual to date
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Final
1
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
300834
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Self funded/Unfunded
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Name [1]
300834
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Patient pays for own treatment
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Address [1]
300834
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Country [1]
300834
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Primary sponsor type
Individual
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Name
Deshan Sebaratnam
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Address
Department of Dermatology, Liverpool Hospital, Liverpool NSW 2170
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Country
Australia
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Secondary sponsor category [1]
300384
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None
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Name [1]
300384
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Address [1]
300384
0
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Country [1]
300384
0
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Ethics approval
Ethics application status
Not required
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Ethics committee name [1]
301603
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Ethics committee address [1]
301603
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Ethics committee country [1]
301603
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Date submitted for ethics approval [1]
301603
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Approval date [1]
301603
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Ethics approval number [1]
301603
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Summary
Brief summary
Deoxycholic acid is a treatment for excess adiposity an an ARTG registered medicine. There are limitations to the total amount that can be administered. In this case, we will treat one side of the body first, then the other side to minimise the total amount of deoxycholic acid administered.
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Trial website
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Trial related presentations / publications
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Public notes
This is a case report documenting the course of a single patient, not an interventional clinical trial. All medical care has followed the principles of the Declaration of Helsinki. Should a formal interventional clinical trial lead on from this study, formal Ethics Committee approval will be obtained.
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Contacts
Principal investigator
Name
87522
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Dr Deshan Sebaratnam
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Address
87522
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Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
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Country
87522
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Australia
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Phone
87522
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+6128833000
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Fax
87522
0
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Email
87522
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[email protected]
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Contact person for public queries
Name
87523
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Dr Deshan Sebaratnam
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Address
87523
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Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
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Country
87523
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Australia
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Phone
87523
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+6128833000
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Fax
87523
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Email
87523
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[email protected]
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Contact person for scientific queries
Name
87524
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Dr Deshan Sebaratnam
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Address
87524
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Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
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Country
87524
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Australia
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Phone
87524
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+6128833000
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Fax
87524
0
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Email
87524
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
This is a report of a single patient. Data reported will include age, sex, ethnicity, treatment dosages and before/after photographs and ultrasound detail
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When will data be available (start and end dates)?
The data will be incorporated into the case report
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Available to whom?
Should the case report be published, it will be accessible through the medical journal in which it is published
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Available for what types of analyses?
The data will be provided as described above to allow for any further analysis as desired by researchers building on the results of this study
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How or where can data be obtained?
By accessing the medical journal
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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