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Recruiting NCT04265599

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

Observational Hypercalcemia Renal Injury Paraffinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypercalcemia, Renal Injury, Paraffinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • previous intramuscular injection of paraffin or other oil

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Herlev Hospital — Copenhagen

Identifiers

NCT: NCT04265599 · VEK RegionH: H-19010297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗