CompletedPhase 2

Phase 2 Study for the Treatment of Superficial Lipomas

United States62 participantsStarted 2007-11

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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: * History of slow growth followed by dormancy, and stable for at least 6 months * Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive * Discrete, oval to rounded in shape, not hard or attached to underlying tissue * Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation) * Located on the trunk, arms, legs, or neck * Signed informed consent. Exclusion Criteria: * Absence of significant medical conditions that could affect safety * History of surgical or deoxycholate treatment for lipomas * Treatment with an investigational agent within 30 days before ATX-101 treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Up to 24 weeks

Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities

Timeframe: 24 weeks

Number of Participants With Clinically Significant Changes in Vital Signs or Weight

Timeframe: Up to 24 weeks

Number of Participants With Positive Histopathology Results at Screening

Timeframe: Screening (prior to randomization)

Number of Participants With Positive Histopathology Results at Week 20

Timeframe: Week 20

Trial details

NCT IDNCT00608842

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2015-12-08

View on ClinicalTrials.gov More Lipoma trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Up to 24 weeks

Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities

Timeframe: 24 weeks

Number of Participants With Clinically Significant Changes in Vital Signs or Weight

Timeframe: Up to 24 weeks

Number of Participants With Positive Histopathology Results at Screening

Timeframe: Screening (prior to randomization)

Number of Participants With Positive Histopathology Results at Week 20

Timeframe: Week 20