A Phase 1/2 interventional study of Prednisolone synthetic cortisone and Isoproterenol together in Lipoma, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-21.
Sponsored by Pennington Biomedical Research Center · Phase 1/2, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Beta-adrenergic agonists and corticosteroid
Drug: Prednisolone synthetic cortisone and Isoproterenol together
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.
Also known as: Prednisolone combined with Isoproterenol
The Average Percent Volume Reduction in the Lipoma.
Time frame: Baseline and 4 weeks
The Number of Lipoma Increased in Volume.
Time frame: After four weeks of treatment up to one year.
The Number of Subjects Elected to Have the Lipoma Removed.
Time frame: After four weeks up to one year.
| Milestone | Prednisolone and Isoproteronol |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
| Percent Volume reduction (cc^3) | Prednisolone and Isoproteronol |
|---|---|
| The Average Percent Volume Reduction in the Lipoma. | 50 ± 0.002 |
| Lipomas | Prednisolone and Isoproteronol |
|---|---|
| The Number of Lipoma Increased in Volume. | 9 |
| participants | Prednisolone and Isoproteronol |
|---|---|
| The Number of Subjects Elected to Have the Lipoma Removed. | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prednisolone and Isoproteronol | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Prednisolone and Isoproteronol |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Prednisolone and Isoproteronol |
|---|---|
| Female | 7 |
| Male | 3 |
| Region of Enrollment(participants) | Prednisolone and Isoproteronol |
|---|---|
| United States | 10 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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