Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil
Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
1 other identifier
observational
200
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2019
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
October 1, 2024
September 1, 2024
7.8 years
February 7, 2020
September 30, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.
at first examination or developed during observation period until 2025
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
PTH level in plasma indicator of hypercalcemia
at first examination or developed during observation period until 2025
Eligibility Criteria
General population
You may qualify if:
- previous intramuscular injection of paraffin or other oil
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Herlev Hospital
Copenhagen, Denmark
Biospecimen
Blood samples Muscle tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator Consultant Endocrinologist MD DMSc
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
April 30, 2019
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share