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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04265599




Registration number
NCT04265599
Ethics application status
Date submitted
7/02/2020
Date registered
11/02/2020
Date last updated
1/10/2024

Titles & IDs
Public title
Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil
Scientific title
Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
Secondary ID [1] 0 0
VEK RegionH: H-19010297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercalcemia 0 0
Renal Injury 0 0
Paraffinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
Timepoint [1] 0 0
at first examination or developed during observation period until 2025
Primary outcome [2] 0 0
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
Timepoint [2] 0 0
at first examination or developed during observation period until 2025

Eligibility
Key inclusion criteria
* previous intramuscular injection of paraffin or other oil
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* none

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen

Funding & Sponsors
Primary sponsor type
Other
Name
Herlev Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.
Trial website
https://clinicaltrials.gov/study/NCT04265599
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ebbe Eldrup, DMSc
Address 0 0
Country 0 0
Phone 0 0
800-045-3868
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04265599