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New treatment option for Lipoma
Official title Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
ClinicalTrials.gov ID: NCT07237425
What this study is testing
What is Ronkyla Plus?
Ronkyla Plus is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for lipoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male or female adults aged 18 to 65 years, inclusive.
- One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2...
- History of slow growth followed by dormancy, and stable for at least 6 months.
- Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue.
You likely can't join if
- History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).
- Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).
- History of diabetes.
- Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)
- A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the...
- Prothrombin time \> 20 seconds.
See the full eligibility criteria
Who can join
- Healthy male or female adults aged 18 to 65 years, inclusive.
- 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:
- History of slow growth followed by dormancy, and stable for at least 6 months.
- Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue.
- Located on the trunk, arms, legs, or neck
- Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma. OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella...
- Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).
- History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.
- The health status is assessed by the investigator as "normal healthy" based on required screening assessments.
- 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...
- Intrauterine device
- Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)
- Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)
- Tubal ligation
- Vasectomized male partner
- Sexual abstinence Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.
- Able and willing to comply with scheduled clinic visits and clinical trial procedures.
- 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/ designee of the sponsor.
What rules you out
- History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).
- Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).
- History of diabetes.
- Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)
- 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 (people being...
- Prothrombin time \> 20 seconds.
- Activated partial thromboplastin time \> 60 seconds.
- INR \> 3.
- Any ongoing medical condition with significant risk of bleeding
- 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/HBV/HCV...
- Administration of an investigational drug within 30 days prior to enrollment.
- Administration of a COVID-19 vaccine within 30 days prior to enrollment.
- Abnormal hepatic and renal functions; hematologic changes at screening:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 X upper limit of normal (ULN).
- Total bilirubin \> 1.5 X ULN.
- Serum creatinine \> 1.5 X ULN.
- Hemoglobin \< lower limit of normal (LLN).
- Platelets ≤ 100.000/mm³.
- Current malignancy of any organ system or a history within 5 years.
- people who, in the opinion of the investigator, are not likely to complete the trial for whatever reason. Part I \& Part II Ronkyla Plus cohort specific exclusion criteria:
- History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.
- Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.
- Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).
- The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology). Part I dose level 2 and 4 cohorts \& Part II specific exclusion criteria:
- History of alcohol or drug abuse within the past year prior to Day 1.
- History of smoking or use of nicotine-containing product within 6 months prior to Day 1.
- Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Da'an District, Taiwan
- New Taipei City, Sijhih District, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Da'an District, Taiwan; New Taipei City, Sijhih District, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.