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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265599
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ebbe Eldrup, MD, DMSc, Herlev Hospital

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
Hypercalcemia Renal Injury Paraffinoma

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Study Type : Observational
Estimated 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 : April 30, 2019
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood samples Muscle tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
General population
Criteria

Inclusion Criteria:

  • previous intramuscular injection of paraffin or other oil

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265599


Contacts
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Contact: Ebbe Eldrup, DMSc +45 38681154 ebbe.eldrup@regionh.dk
Contact: Simone Theilade, DMSc karen.simone.theilade@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Copenhagen, Denmark
Contact: Ebbe Eldrup, DMSc    +45 38681154    ebbe.eldrup@regionh.dk   
Contact: Simone Theilade, DMSc       karen.simone.theilade@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Ebbe Eldrup, DMSc Herlev Hospital

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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: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance