A Phase 1 interventional study of Deoxycholic Acid Injection and Placebo in Lipoma, sponsored by Kythera Biopharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by Kythera Biopharmaceuticals (part of AbbVie) · Phase 1, Interventional, and Treatment
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.
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.)
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's enrollment of 16 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →Kythera Biopharmaceuticals is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted before Kythera Biopharmaceuticals became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One or more 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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Drug: Deoxycholic Acid Injection
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Drug: Deoxycholic Acid Injection
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Drug: Deoxycholic Acid Injection
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Drug: Deoxycholic Acid Injection
Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Drug: Placebo
Administered via intralipomal injection.
Also known as: ATX-101, Sodium deoxycholate
Administered via intralipomal injection.
Assessments of Safety with Laboratory tests
Time frame: up to 16 weeks
Assessments of Safety with ECG
Time frame: up to 16 weeks
Assessments of Safety with Medical Evaluations
Time frame: up to 16 weeks
Lipoma size reduction
Time frame: up to 16 weeks
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deoxycholic Acid