Lipoma clinical trials

For general information, Learn About Clinical Studies. One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Phase 2 Study for the Treatment of Superficial Lipomas The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : January 14, Last Update Posted : January 14, Study 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.

Detailed Description:. A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated.

Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated. FDA Resources. Arms and Interventions. Other Names: sodium deoxycholate ATX This is a multi-center, randomized, double blind, placebo controlled clinical trial in DD subjects having lipomas.

Subjects will be randomized, in a ratio, into two groups injected with either RZL or vehicle. Once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will be offered the option of receiving treatment with RZL and followed up for an additional 84 days.

Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0. A single-treatment injection, multiple subcutaneous injections of vehicle administered into lipomas in each subject, preferably 6. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies RZL for Dercum's Disease Lipomas The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : February 26, Study Description.

Thirty-eight 38 subjects will be included in the study. Subjects must present with 2 lipomas; one to receive AA and one to receive placebo simultaneously. Outcome Measures. Primary Outcome Measures : Percent Change From Baseline in Surface Area of the Lipoma at Six Months [ Time Frame: Baseline and 6 months post injection ] The primary efficacy outcome is lipoma visible surface area defined as the longest dimension "length" times the longest dimension perpendicular to length "width".

Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA and the lipoma treated with placebo. Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire.

Other Outcome Measures: Change in Visible Surface Area [ Time Frame: 1 Month post injection ] Visible surface area is defined as the longest dimension "length" times the longest dimension perpendicular to length "width".

Visible surface area is defined as the longest dimension "length" times the longest dimension perpendicular to length "width". Eligibility Criteria.

Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U.

Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: AA Drug: placebo. Phase 2.