[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lipoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lipoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,70,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100579120","phase-1-lipomas-treated-with-subcutaneous-injections-of-cooled-or-warmed-sodium-chloride-100579120",false,"NCT06820164","Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride","Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study","Inclusion Criteria:\n\n* At least one clinically diagnosed subcutaneous lipoma\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Participant has a lipoma on the face\n* Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas)\n* Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume)\n* Rapidly growing lipomas\n* Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)\n* Pregnant women",true,"ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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\u002For 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.\n\nAmendment to Protocol Feb 2026- Including and additional ARM of the study to evaluate the effectiveness of subcutaneous injections of warmed normal saline as a treatment option for lipomas.",[28],"Lipoma","RECRUITING","2026-04-23",{"date":32,"type":33},"2026-04-29","ACTUAL",{"date":35,"type":33},"2025-05-08",{"date":37,"type":21},"2027-01",{"name":39,"class":40},"West Virginia University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100611195","phase-1-intralesional-ronkyla-plus-injection-for-the-treatment-of-superficial-lipoma-100611195","NCT07237425","Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma","A Safety, Efficacy and Pharmacokinetic Evaluation Study of Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma","Inclusion Criteria:\n\n1. Healthy male or female adults aged 18 to 65 years, inclusive.\n2. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:\n\n   * History of slow growth followed by dormancy, and stable for at least 6 months.\n   * Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.\n   * Discrete, oval to rounded in shape, not hard or attached to underlying tissue.\n   * Located on the trunk, arms, legs, or neck\n   * Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma.\n\n   OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)\n3. Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).\n4. History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.\n5. The health status is assessed by the investigator as \"normal healthy\" based on required screening assessments.\n6. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of contraception from enrollment up to the study end, such as:\n\n   * Intrauterine device\n   * Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)\n   * Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)\n   * Tubal ligation\n   * Vasectomized male partner\n   * Sexual abstinence\n\n   Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.\n7. Able and willing to comply with scheduled clinic visits and clinical trial procedures.\n8. Capable of understanding and giving signed informed consent form after full discussion of the research nature of the treatment and its risk and benefits with the investigator\u002F designee of the sponsor.\n\nExclusion Criteria:\n\n1. History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).\n2. Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).\n3. History of diabetes.\n4. Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)\n5. A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any clinically significant bleeding disorder (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day washout period):\n\n   * Prothrombin time \\> 20 seconds.\n   * Activated partial thromboplastin time \\> 60 seconds.\n   * INR \\> 3.\n6. Any ongoing medical condition with significant risk of bleeding\n7. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV\u002FHBV\u002FHCV, or clinically significant laboratory findings that would, in the investigator's judgment, make the subject inappropriate for the study.\n8. Administration of an investigational drug within 30 days prior to enrollment.\n9. Administration of a COVID-19 vaccine within 30 days prior to enrollment.\n10. Abnormal hepatic and renal functions; hematologic changes at screening:\n\n    * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 X upper limit of normal (ULN).\n    * Total bilirubin \\> 1.5 X ULN.\n    * Serum creatinine \\> 1.5 X ULN.\n    * Hemoglobin \\\u003C lower limit of normal (LLN).\n    * Platelets ≤ 100.000\u002Fmm³.\n11. Current malignancy of any organ system or a history within 5 years.\n12. Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.\n\nPart I \\& Part II Ronkyla Plus cohort specific exclusion criteria:\n\n1. History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.\n2. Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.\n3. Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).\n4. The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology).\n\nPart I dose level 2 and 4 cohorts \\& Part II specific exclusion criteria:\n\n1. History of alcohol or drug abuse within the past year prior to Day 1.\n2. History of smoking or use of nicotine-containing product within 6 months prior to Day 1.\n3. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.","65 Years",{"count":51,"type":21},56,[24],"This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.",[28,55],"Submental Fullness",[57,58],"ATX-101","Ronkyla Plus","2025-11-26",{"date":61,"type":33},"2025-12-04",{"date":63,"type":33},"2025-11-14",{"date":65,"type":21},"2027-01-14",{"name":67,"class":68},"Glonova Pharma Co., Ltd","INDUSTRY",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":41},"100585503","rfa-for-superficial-lipomas-100585503","NCT06903208","RFA for Superficial Lipomas","Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas","Inclusion Criteria:\n\n* Patients \\>18 years old\n* Patients with a lipoma \\\u003C5 cm, above the fascia on the trunk, abdomen or extremities\n\nExclusion Criteria:\n\n* Lipomas of the face or neck\n* Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass)\n* Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome\n* A history of exposure to herbicides, arsenic and dioxin\n* A history of radiation treatment for other cancers",{"count":78,"type":21},10,[80],"NA","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.\n\nRadiofrequency 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.",[28],[84,85,86,87,88,89],"lipoma","ablation","fatty tissue","fatty tumor","scarring","minimally invasive","2025-07-15",{"date":92,"type":33},"2025-07-18",{"date":94,"type":33},"2025-04-02",{"date":96,"type":21},"2026-12",{"name":98,"class":40},"Columbia University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":69},"100594032","evaluating-the-efficacy-and-safety-of-embella-deoxycholic-acid-produced-by-espad-pharmed-co-injection-in-the-management-of-superficial-lipomas-100594032","NCT07014163","Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas","Inclusion Criteria:\n\n1. Men and women aging between 18 to 65 years\n2. Having at least one lipoma (based on clinical and sonographic diagnosis), which is accessible for treatment and assessment and is quantifiable along at least 2 perpendicular diameters and lower than 2 centimeter in depth, with the following characteristics:\n\n   * History of slow growth followed by dormancy\n   * Being stable for at least 6 months\n   * Greatest length by greatest perpendicular width between 4 and 4 square centimeters\n   * Inclusive discrete, oval to rounded in shape, not hard or attached to underlying tissue\n   * Located on the trunk, upper and lower limbs, far from main and vulnerable neurovascular structures\n3. Stable body weight with a body mass index of less than 30 kg\u002Fm² in the past three months\n4. Signed informed consent\n5. Ability to follow study instructions and likely to complete all required visits\n6. Agreement to abstain from any treatment for lipomas during the study\n\nExclusion Criteria:\n\n1. Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders) that, in the opinion of the attending physician, affect the evaluation of the efficacy and safety of the product.\n2. Known allergy or sensitivity to the study medication or its components\n3. Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of study\n4. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.\n5. Previous treatment for lipomas\n6. Subjects planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation\n7. Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome) or HIV-related disease\n8. Evidence of recent alcohol or drug abuse\n9. Medical and\u002For psychiatric problems that are severe enough to interfere with the study results\n10. Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection\n11. Having a tendency to develop hypertrophic scarring\n12. Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein\n13. Having an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma\n14. Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study",{"count":78,"type":21},[80],"Lipoma is a relatively common, slow-growing mesenchymal neoplasm originating from adipose tissue. Patients seek treatment for lipomas for various reasons, such as concerns about their growth and spread, aesthetic issues, or worries about the compressive effects of the lipoma. Lipomas are typically removed surgically through excision, which can have complications including bleeding, infection, scarring, and recurrence. Other mentioned treatment methods include liposuction, laser, and medicinal approaches.\n\nPurified synthetic deoxycholic acid has been introduced as the first pharmacological intervention approved by the FDA for the reduction of submental fat. Deoxycholic acid is a type of bile acid that, due to its ability to cause non-selective cell lysis and disruption of adipocyte membranes (adipocytolysis), leads to emulsification of fat in the intestine.\n\nThis is an interventional (pre-post), single-arm, and open-label study to evaluate the efficacy and safety of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) for the management of superficial lipomas.",[28],"2025-06-09",{"date":111,"type":33},"2025-06-10",{"date":113,"type":33},"2024-05-21",{"date":115,"type":21},"2026-06-20",{"name":117,"class":68},"Espad Pharmed"]