Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil

Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04265599

Enrollment

200

Registered

2020-02-11

Start date

2019-04-30

Completion date

2027-01-31

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercalcemia, Paraffinoma, Renal Injury

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* previous intramuscular injection of paraffin or other oil

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia	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	at first examination or developed during observation period until 2025	PTH level in plasma indicator of hypercalcemia

Countries

Denmark

Contacts

Primary ContactEbbe Eldrup, DMSc

ebbe.eldrup@regionh.dk800-045-3868

Backup ContactMartin Blomberg Jensen, DMSc

blombergjensen@gmail.com

Outcome results