Trial · NCT01613313
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
NCT01613313, Phase 2, Completed, Zachary Gerut; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma. Trials, record NCT01613313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01613313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
- NCT number
- NCT01613313
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Zachary Gerut
- Conditions
- Lipoma
- Interventions
- Collagenase Clostridium Histolyticum
- First posted
- 2012-06-07
- Last updated
- 2016-10-06
- Results first posted
- 2016-03-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Visible Surface Area of the Lipoma | Baseline and Six months post injection of study drug | The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit. |
| Secondary | Relative Change in Volume of the Lipoma | Baseline and 6 months post injection of study drug | A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Visible Surface Area of the Lipoma | Baseline and Six months post injection of study drug | Analysis population consists of all subjects who were enrolled and received the administration of study drug. | Percent change from baseline | MEAN |
| SECONDARY | Relative Change in Volume of the Lipoma | Baseline and 6 months post injection of study drug | Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug | Percent reduction from baseline | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Visible Surface Area of the Lipoma | Dose #1 | -31.69 | Standard Deviation 80.83 | Percent change from baseline | |
| Change in Visible Surface Area of the Lipoma | Dose #2 | -47.57 | Standard Deviation 23.48 | Percent change from baseline | |
| Change in Visible Surface Area of the Lipoma | Dose #3 | -52.42 | Standard Deviation 50.61 | Percent change from baseline | |
| Change in Visible Surface Area of the Lipoma | Dose #4 | -66.60 | Standard Deviation 17.82 | Percent change from baseline | |
| Relative Change in Volume of the Lipoma | Dose #1 | -54.16 | Standard Deviation 34.3 | Percent reduction from baseline | |
| Relative Change in Volume of the Lipoma | Dose #2 | -62.33 | Standard Deviation 30.39 | Percent reduction from baseline | |
| Relative Change in Volume of the Lipoma | Dose #3 | -11.35 | Standard Deviation 32.12 | Percent reduction from baseline | |
| Relative Change in Volume of the Lipoma | Dose #4 | -34.75 | Standard Deviation 24.21 | Percent reduction from baseline |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose #1 | 2 | |
| Overall Study | STARTED | Dose #2 | 4 | |
| Overall Study | STARTED | Dose #3 | 4 | |
| Overall Study | STARTED | Dose #4 | 4 | |
| Overall Study | COMPLETED | Dose #1 | 2 | |
| Overall Study | COMPLETED | Dose #2 | 4 | |
| Overall Study | COMPLETED | Dose #3 | 4 | |
| Overall Study | COMPLETED | Dose #4 | 4 | |
| Overall Study | NOT COMPLETED | Dose #1 | 0 | |
| Overall Study | NOT COMPLETED | Dose #2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Bruising | General disorders | Dose #1 | 1 | 2 | |
| other | Bruising | General disorders | Dose #2 | 3 | 4 | |
| other | Bruising | General disorders | Dose #3 | 3 | 4 | |
| other | Bruising | General disorders | Dose #4 | 4 | 4 | |
| other | Pain | General disorders | Dose #1 | 0 | 2 | |
| other | Pain | General disorders | Dose #2 | 3 | 4 | |
| other | Pain | General disorders | Dose #3 | 1 | 4 | |
| other | Pain | General disorders | Dose #4 | 3 | 4 | |
| other | Swelling | General disorders | Dose #1 | 0 | 2 | |
| other | Swelling | General disorders | Dose #2 | 0 | 4 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose #1 | ||
| Total, all-cause mortality | Dose #2 | ||
| Total, all-cause mortality | Dose #3 | ||
| Total, all-cause mortality | Dose #4 | ||
| Total, other adverse events | Dose #1 | 1 | 2 |
| Total, other adverse events | Dose #2 | 3 | 4 |
| Total, other adverse events | Dose #3 | 3 | 4 |
| Total, other adverse events | Dose #4 | 4 | 4 |
| Total, serious adverse events | Dose #1 | 0 | 2 |
| Total, serious adverse events | Dose #2 | 0 | 4 |
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/NCT01613313
GET https://conductscience.org/api/trials/v1/NCT01613313/events?page=2