A Phase 2 interventional study of Deoxycholic Acid Injection and Placebo in Lipoma, sponsored by Kythera Biopharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by Kythera Biopharmaceuticals (part of AbbVie) · Phase 2, Interventional, and Treatment
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.
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 62 is above 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.
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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:
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.
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.
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 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
Drug: Placebo
Administered via intralipomal injection.
Also known as: sodium deoxycholate, ATX-101
Matching vehicle placebo administered via intralipomal injection.
Number of Participants With Adverse Events (AEs)
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Time frame: Up to 24 weeks
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Time frame: 24 weeks
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Time frame: Up to 24 weeks
Number of Participants With Positive Histopathology Results at Screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Time frame: Screening (prior to randomization)
Number of Participants With Positive Histopathology Results at Week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
Time frame: Week 20
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response.
Time frame: Baseline and week 20 (8 weeks after last dose)
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size.
Time frame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)
| Milestone | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Started | 15 | 15 | 15 | 17 |
| Completed | 14 | 14 | 13 | 16 |
| Not completed | 1 | 1 | 2 | 1 |
| Withdrew: Participant's request | 0 | 1 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
| participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Any adverse event | 12 | 13 | 14 | 12 |
| Any treatment-related adverse event | 6 | 9 | 8 | 7 |
| Any serious adverse event | 1 | 0 | 1 | 0 |
| Any severe adverse event | 1 | 1 | 2 | 0 |
| Any adverse event leading to drug discontinuation | 1 | 0 | 3 | 0 |
At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response.
| percentage of participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Complete Clearance | 0.0 | 0.0 | 7.1 | 0.0 |
| ≥ 75% Cleared | 13.3 | 6.7 | 14.3 | 11.8 |
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
| participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Blood triglycerides | 0 | 0 | 1 | 0 |
| Alanine transaminase | 0 | 0 | 1 | 0 |
| Aspartate aminotransferase | 0 | 0 | 1 | 0 |
| Alkaline phosphatase | 0 | 0 | 1 | 0 |
| Urinalysis - Glucose | 0 | 0 | 1 | 0 |
Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size.
| percent change | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Week 12 | 41.2 ± 31.5 | 28.5 ± 46.0 | 18.0 ± 34.9 | 38.5 ± 32.4 |
| Week 16 | 43.9 ± 30.1 | 23.3 ± 41.8 | 20.0 ± 38.2 | 32.1 ± 40.5 |
| Week 20 | 50.1 ± 30.6 | 25.9 ± 42.6 | 35.9 ± 40.7 | 36.7 ± 38.0 |
| participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs or Weight | 0 | 0 | 0 | 0 |
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
| participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Acute inflammation | 0 | 0 | 1 | 0 |
| Chronic inflammation | 0 | 0 | 0 | 0 |
| Fibrosis/scarring | 0 | 0 | 1 | 0 |
| Hemorrhage | 0 | 0 | 2 | 1 |
| Mature adipose tissue | 11 | 11 | 13 | 13 |
| Necrosis | 0 | 0 | 0 | 0 |
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
| participants | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Acute inflammation | 3 | 2 | 1 | 0 |
| Chronic inflammation | 10 | 12 | 13 | 0 |
| Fibrosis/scarring | 13 | 12 | 14 | 6 |
| Hemorrhage | 5 | 5 | 6 | 2 |
| Mature adipose tissue | 15 | 13 | 15 | 16 |
| Necrosis | 14 | 13 | 14 | 3 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deoxycholic Acid 1% | — | 1/15 (6.7%) | 12/15 (80%) |
| Deoxycholic Acid 2% | — | 0/15 (0%) | 13/15 (86.7%) |
| Deoxycholic Acid 4% | — | 1/15 (6.7%) | 14/15 (93.3%) |
| Placebo | — | 0/17 (0%) | 12/17 (70.6%) |
| Event | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Patella FractureMusculoskeletal and connective tissue disorders | 1/15 | 0/15 | 0/15 | 0/17 |
| Tibia FractureMusculoskeletal and connective tissue disorders | 1/15 | 0/15 | 0/15 | 0/17 |
| Breast CancerReproductive system and breast disorders | 0/15 | 0/15 | 1/15 | 0/17 |
| Event | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo |
|---|---|---|---|---|
| Injection Site ErythemaGeneral disorders | 6/15 | 6/15 | 4/15 | 3/17 |
| Injection Site BruisingGeneral disorders | 3/15 | 4/15 | 6/15 | 5/17 |
| Injection Site PainGeneral disorders | 3/15 | 4/15 | 5/15 | 3/17 |
| Injection Site IndurationGeneral disorders | 2/15 | 3/15 | 3/15 | 3/17 |
| Injection Site AnaesthesiaGeneral disorders | 2/15 | 3/15 | 2/15 | 3/17 |
| Injection Site DiscolourationGeneral disorders | 3/15 | 3/15 | 3/15 | 1/17 |
| Injection Site PruritusGeneral disorders | 3/15 | 3/15 | 1/15 | 0/17 |
| Injection Site SwellingGeneral disorders | 2/15 | 1/15 | 3/15 | 1/17 |
| NasopharyngitisInfections and infestations | 3/15 | 3/15 | 3/15 | 2/17 |
| InfluenzaInfections and infestations | 3/15 | 0/15 | 1/15 | 1/17 |
Modified intent-to-treat (MITT) population included all randomized participants who had received at least 1 dose of study material and who had at least 1 postbaseline observation.
| Age, Continuous(years) | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 45.9 ± 9.5 | 48.5 ± 9.1 | 49.5 ± 10.5 | 45.5 ± 8.9 | 47.2 ± 9.4 |
| Sex: Female, Male(Participants) | Deoxycholic Acid 1% | Deoxycholic Acid 2% | Deoxycholic Acid 4% | Placebo | Total |
|---|---|---|---|---|---|
| Female | 5 | 5 | 3 | 6 | 19 |
| Male | 10 | 10 | 11 | 11 | 42 |
The record gives a start of Nov 2007, a primary completion of Aug 2008 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2016, 7 years 5 months after primary completion. A results delay was requested in May 2014.
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Studies of the drug tested here: Deoxycholic Acid