Trial Information

A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

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.