Clinical trial: RZL-012 for Dercum's Disease Lipomas (NCT04229030)

Eligibility criteria:
Inclusion Criteria:

          -  At least 4 painful lipomas of appropriate size to be injected on a background of
             Dercum's Disease.

          -  Generally considered healthy according to medical history, physical examination,
             electrocardiogram (ECG) and laboratory evaluation with an emphasis on metabolic
             parameters (fasting glucose concentration < 200 mg/dL).

          -  Subjects must be able to adhere to the visit schedule and protocol requirements and be
             capable of completing the study.

          -  Males or females in the age of fertility are willing to refrain from sexual activity
             or agree to use a double-barrier contraceptive device (e.g., condom and spermicide)
             for 4 weeks after treatment with RZL 012.

          -  Subjects must sign an informed consent indicating they are aware of the
             investigational nature of the study.

        Exclusion Criteria:

          -  Unable to tolerate subcutaneous injections.

          -  Pregnant women.

          -  Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric
             disorders, that in the opinion of the investigator places the subject at significant
             risk.

          -  Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus
             (HCV), or Human immunodeficiency virus (HIV).

          -  Subjects with a clinical history of active primary or secondary immunodeficiency,
             autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids

          -  Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or
             cholecystitis.

          -  As a result of medical review and 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.

          -  Subjects treated chronically at least 3 months prior to study entry with systemic
             steroids or immunosuppressive drugs.

          -  Subjects treated chronically at least one week prior to study entry with Non-Steroidal
             Anti-Inflammatory Drugs (NSAIDs).

          -  Current participation or participation within 3 months prior to the start of this
             study in a drug or other investigational research study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? 0