Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Der… (NCT03492840) | Clinical Trial Compass
CompletedPhase 2
Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
United States12 participantsStarted 2018-06-28
Plain-language summary
This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will receive RZL-012.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. Post-menopausal (at least 2 years) women no more than 65 years old, with lipedema involving substantial fat above the knee or nodular Dercum's disease in such women and in men 20 - 65 years with nodular Dercum's disease.
✓. For Dercum's disease subjects - at least 2 nodules to be injected of at least 2cm diameter each, as determined by ultrasound
✓. For lipedema subjects - Significant subcutaneous fat above the knee as determined by circumference of 50cm
✓. Generally considered healthy according to medical history, physical examination, ECG and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration \< 100 mg, normal blood pressure).
✓. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
✓. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
Exclusion criteria
✕. Unable to tolerate subcutaneous injection.
✕. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator, put the subject at significant risk, are not eligible.
✕. Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV), or positive urine screen for alcohol or drugs of abuse (unless prescribed by a physician).
✕
What they're measuring
1
The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort
. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
✕. As a result of medical review, physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
✕. Known sensitivity to components of the injection formulation.
✕. Prior wound, tattoo or infection in the treated area.
✕. Prior invasive treatment such as surgery or injectable drug at the RZL-012 injected area.