Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Herlev Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •previous intramuscular injection of paraffin or other oil
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
Time Frame: at first examination or developed during observation period until 2025
Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
Time Frame: at first examination or developed during observation period until 2025
PTH level in plasma indicator of hypercalcemia
Secondary Outcomes
No secondary outcomes reported
Investigators
Ebbe Eldrup, MD, DMSc
Principal investigator Consultant Endocrinologist MD DMSc
Herlev Hospital