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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
Scientific title
Deoxycholic acid as treatment of abdominal adiposity
Secondary ID [1] 296235 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal adiposity 309875 0
Condition category
Condition code
Skin 308667 308667 0 0
Other skin conditions
Diet and Nutrition 308712 308712 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 312562 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307633 0
Subjective reduction in abdominal fat as reported by patient using a visual analogue scale graded from 0 (no change) to 10 (best possible change)
Timepoint [1] 307633 0
16-24 weeks from the first treatment administration
Secondary outcome [1] 352460 0
Objective reduction in abdominal fat as assessed by ultrasound
Timepoint [1] 352460 0
16-24 weeks from the first treatment administration

Eligibility
Key inclusion criteria
Self-reported abdominal adiposity recalcitrant to diet and exercise
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years old, inability to give consent, allergy to deoxycholic acid

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 300834 0
Self funded/Unfunded
Name [1] 300834 0
Patient pays for own treatment
Address [1] 300834 0
Country [1] 300834 0
Primary sponsor type
Individual
Name
Deshan Sebaratnam
Address
Department of Dermatology, Liverpool Hospital, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 300384 0
None
Name [1] 300384 0
Address [1] 300384 0
Country [1] 300384 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 301603 0
Ethics committee address [1] 301603 0
Ethics committee country [1] 301603 0
Date submitted for ethics approval [1] 301603 0
Approval date [1] 301603 0
Ethics approval number [1] 301603 0

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.
Trial website
Trial related presentations / publications
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.

Contacts
Principal investigator
Name 87522 0
Dr Deshan Sebaratnam
Address 87522 0
Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
Country 87522 0
Australia
Phone 87522 0
+6128833000
Fax 87522 0
Email 87522 0
z3159591@unsw.edu.au
Contact person for public queries
Name 87523 0
Dr Deshan Sebaratnam
Address 87523 0
Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
Country 87523 0
Australia
Phone 87523 0
+6128833000
Fax 87523 0
Email 87523 0
z3159591@unsw.edu.au
Contact person for scientific queries
Name 87524 0
Dr Deshan Sebaratnam
Address 87524 0
Department of Dermatology, Liverpool Hospital, Liverpool, NSW 2170
Country 87524 0
Australia
Phone 87524 0
+6128833000
Fax 87524 0
Email 87524 0
z3159591@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
The data will be incorporated into the case report
Available to whom?
Should the case report be published, it will be accessible through the medical journal in which it is published
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
How or where can data be obtained?
By accessing the medical journal
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary