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

Sponsor
Herlev Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04265599
Collaborator
(none)
200
Enrollment
1
Location
69.1
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
    Actual Study Start Date :
    Apr 30, 2019
    Anticipated Primary Completion Date :
    Jan 31, 2025
    Anticipated Study Completion Date :
    Jan 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • previous intramuscular injection of paraffin or other oil
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herlev Hospital Copenhagen Denmark

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

    • Principal Investigator: Ebbe Eldrup, DMSc, Herlev Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebbe Eldrup, MD, DMSc, Principal investigator Consultant Endocrinologist MD DMSc, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT04265599
    Other Study ID Numbers:
    • VEK RegionH: H-19010297
    First Posted:
    Feb 11, 2020
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypercalcemia

    Study Results

    No Results Posted as of Aug 25, 2021