Treatment Trials

15 Clinical Trials for Various Conditions

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RECRUITING
RFA for Superficial Lipomas
Description

Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable. Radiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.

Conditions
RECRUITING
Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride
Description

Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas.

Conditions
COMPLETED
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Description

The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

Conditions
COMPLETED
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Description

The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it.

Conditions
COMPLETED
Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Description

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.

Conditions
COMPLETED
Phase 2 Study for the Treatment of Superficial Lipomas
Description

The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.

Conditions
COMPLETED
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Description

The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

Conditions
RECRUITING
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas
Description

This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.

COMPLETED
Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
Description

The specific aims of this proposal are to: Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in Visual Analog Scale (VAS) back pain scores, VAS leg pain scores, and Oswestry Disability Index (ODI) , as well as SCS complication rate. The specific aims of this proposal are to: Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in VAS back pain scores, VAS leg pain scores, and Oswestry Disability Index, as well as SCS complication rate.

COMPLETED
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
Description

This Phase 2 study will be an open-label and randomized study to assess the efficacy and safety of CBL-514 in participants with Dercum's Disease lipomas.

ACTIVE_NOT_RECRUITING
Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)
Description

Patients (homozygous MFN2 \[gene that provides instructions to produce the Mitofusin 2 protein\] R707W) will be treated with Metreleptin, and effects on body composition, metabolic parameters and safety will be assessed over a 6 month intervention period. Additional safety will be assessed for 1 more year (up to 1.5 years total) in which adverse event data will be collected.

COMPLETED
RZL-012 for Dercum's Disease Lipomas
Description

Thirty-eight (38) subjects will be included in the study. Subjects will be randomized in a ration of 1:1 to be treated with RZL-012 or placebo. Subjects will be injected with a different doses of RZL-012 according to their lipomas sizes. The total of 38 subjects will be enrolled in 3 clinical sites.

RECRUITING
Identification of Biomarkers for Patients with Vascular Anomalies
Description

The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the Department of Hematology/Oncology.

UNKNOWN
Insight Into Subcutaneous Adipose Tissue Disorders
Description

The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT) disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT in these disorders that is resistant to diet and exercise.

UNKNOWN
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning
Description

The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.