Trial · NCT00608842
Phase 2 Study for the Treatment of Superficial Lipomas
NCT00608842, Phase 2, Completed, Kythera Biopharmaceuticals; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study for the Treatment of Superficial Lipomas. Trials, record NCT00608842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study for the Treatment of Superficial Lipomas
- NCT number
- NCT00608842
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Kythera Biopharmaceuticals
- Conditions
- Lipoma
- Interventions
- Deoxycholic Acid Injection, Placebo
- First posted
- 2008-02-06
- Last updated
- 2016-01-14
- Results first posted
- 2016-01-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | Up to 24 weeks | 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. |
| Primary | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | 24 weeks | An abnormality is defined as a value outside the limits of the expanded normal range/notable range. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | Up to 24 weeks | |
| Primary | Number of Participants With Positive Histopathology Results at Screening | Screening (prior to randomization) | A needle core tissue sample biopsy was performed at screening for all treated lipomas. |
| Primary | Number of Participants With Positive Histopathology Results at Week 20 | 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. |
| Secondary | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Baseline and week 20 (8 weeks after last dose) | 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. |
| Secondary | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Up to 24 weeks | Safety population (all participants who received at least 1 dose of study medication) | participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | Baseline and week 20 (8 weeks after last dose) | MITT Population | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | 24 weeks | Safety population | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) | MITT Population | percent change | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | Up to 24 weeks | Safety population | participants | NUMBER |
| PRIMARY | Number of Participants With Positive Histopathology Results at Screening | Screening (prior to randomization) | Safety population with biopsy results at screening | participants | NUMBER |
| PRIMARY | Number of Participants With Positive Histopathology Results at Week 20 | Week 20 | Safety population with biopsy results at week 20 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 1% | Any adverse event | 12 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 2% | Any adverse event | 13 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 4% | Any adverse event | 14 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo | Any adverse event | 12 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 1% | Any treatment-related adverse event | 6 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 2% | Any treatment-related adverse event | 9 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 4% | Any treatment-related adverse event | 8 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo | Any treatment-related adverse event | 7 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 1% | Any serious adverse event | 1 | participants | |
| Number of Participants With Adverse Events (AEs) | Deoxycholic Acid 2% | Any serious adverse event | 0 | participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Deoxycholic Acid 1% | 15 | |
| Overall Study | STARTED | Deoxycholic Acid 2% | 15 | |
| Overall Study | STARTED | Deoxycholic Acid 4% | 15 | |
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | COMPLETED | Deoxycholic Acid 1% | 14 | |
| Overall Study | COMPLETED | Deoxycholic Acid 2% | 14 | |
| Overall Study | COMPLETED | Deoxycholic Acid 4% | 13 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Deoxycholic Acid 1% | 1 | |
| Overall Study | NOT COMPLETED | Deoxycholic Acid 2% | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events232
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection Site Erythema | General disorders | Deoxycholic Acid 1% | 6 | 15 | |
| other | Injection Site Erythema | General disorders | Deoxycholic Acid 2% | 6 | 15 | |
| other | Injection Site Erythema | General disorders | Deoxycholic Acid 4% | 4 | 15 | |
| other | Injection Site Erythema | General disorders | Placebo | 3 | 17 | |
| other | Injection Site Bruising | General disorders | Deoxycholic Acid 1% | 3 | 15 | |
| other | Injection Site Bruising | General disorders | Deoxycholic Acid 2% | 4 | 15 | |
| other | Injection Site Bruising | General disorders | Deoxycholic Acid 4% | 6 | 15 | |
| other | Injection Site Bruising | General disorders | Placebo | 5 | 17 | |
| other | Injection Site Pain | General disorders | Deoxycholic Acid 1% | 3 | 15 | |
| other | Injection Site Pain | General disorders | Deoxycholic Acid 2% | 4 | 15 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Deoxycholic Acid 1% | ||
| Total, all-cause mortality | Deoxycholic Acid 2% | ||
| Total, all-cause mortality | Deoxycholic Acid 4% | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Deoxycholic Acid 1% | 12 | 15 |
| Total, other adverse events | Deoxycholic Acid 2% | 13 | 15 |
| Total, other adverse events | Deoxycholic Acid 4% | 14 | 15 |
| Total, other adverse events | Placebo | 12 | 17 |
| Total, serious adverse events | Deoxycholic Acid 1% | 1 | 15 |
| Total, serious adverse events | Deoxycholic Acid 2% | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00608842
GET https://conductscience.org/api/trials/v1/NCT00608842/results?page=2