Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Condition: Lipoma
MeSH terms: Lipoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test whether injected medications will increase the amount of
      fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined
      with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also
      test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which
      are benign fatty tumors.
    

Detailed description: 
      Lipomas are benign, non-cancerous fatty tumors that occur under the skin and make a bump that
      can be easily felt and often seen. The current treatment for lipomas is surgery.
      Isoproterenol, a medication used for the treatment of asthma and approved for injection under
      the skin, is known to cause fat cells to give up their fat. The fat cells become resistant to
      isoproterenol with repeated use. Prednisolone, a synthetic cortisone medication used to treat
      immune problems like allergy and approved for injection under the skin, keeps the fat cells
      from becoming resistant to isoproterenol. It is not known, if the fat cells in lipomas act
      like other fat cells or if the combination of isoproterenol and prednisolone injections would
      shrink lipomas without surgery. This study is designed to test this possibility.

      Subjects will have a screening visit, 2 microdialysis visits a week apart, 20 treatment
      visits 5 days per week for 4 weeks, and up to 12 follow-up visits a year after treatment
      visits. During screening, subjects will have a history, physical exam, blood testing,
      electrocardiogram and a pregnancy testing if female with reproductive capacity. The first
      microdialysis visit will consist of placing two microdialysis catheters under the skin after
      the area is numbed. One microdialysis catheter will be in the lipoma and the other under the
      skin 2 inches away. The microdialysis catheter will connect to a pump, isoproterenol will be
      infused and the amount of fat breakdown measured. One week later prednisolone will be
      injected into the lipoma and under the skin 2 inches away. The microdialysis visit will be
      repeated 24 hours later.

      Treatment will consist of injecting the lipoma 5 days a week with a mixture of isoproterenol
      and prednisolone in the Pennington clinic as a diabetic would inject insulin. Each week the
      blood pressure, pulse and lipoma will be measured and subjects will be asked how they feel.
      At the end of the treatment period the physical examination, blood test and electrocardiogram
      will be repeated.

      The insertion of the microdialysis probes under the skin into the fat tissue could be
      uncomfortable, but numbing medication will be injected first to prevent this problem. At
      higher doses, isoproterenol could lower blood pressure and increase pulse rate. This should
      not happen at the doses used, but blood pressure and pulse will be monitored throughout the
      study. Prednisolone, at higher doses, could decrease the body's production of cortisone. This
      should not happen at the doses being used, but cortisone in the body will be measured during
      the trial. Blood tests involve the discomfort of a needle going through the skin of the arm,
      possible bruising and rarely fainting or infection. Trained technicians and sterile needles
      will minimize these risks.
    

Intervention name(s): Prednisolone synthetic cortisone and Isoproterenol together
Intervention type(s): Drug
Intervention description(s): Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
Other intervention name(s): Prednisolone combined with Isoproterenol
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cortisone; Isoproterenol; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity therapy; fat; drug mechanism; adipose tissue; cellular pharmacology