Trial · NCT02249052
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
NCT02249052, Phase 2, Completed, Gerut, Zachary, M.D.; results first posted 2016-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma. Trials, record NCT02249052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02249052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
- NCT number
- NCT02249052
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Gerut, Zachary, M.D.
- Conditions
- Lipoma
- Interventions
- AA4500, placebo
- First posted
- 2014-09-25
- Last updated
- 2017-02-23
- Results first posted
- 2016-12-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Surface Area of the Lipoma at Six Months | Baseline and 6 months post injection | The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit. |
| Secondary | Responder Analysis | Baseline and 6 months | The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline |
| Secondary | Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months | Baseline and 6 months | Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo. |
| Secondary | Subject Satisfaction | 6 months | Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire |
| Other | Change in Visible Surface Area | 1 Month post injection | Visible surface area is defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline. |
| Other | Change in Visible Surface Area | 3 month post injection | Visible surface area is defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Surface Area of the Lipoma at Six Months | Baseline and 6 months post injection | All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma. | percentage change from baseline | MEAN |
| SECONDARY | Responder Analysis | Baseline and 6 months | All 19 participants | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months | Baseline and 6 months | All study participants | Percent change from baseline | MEAN |
| SECONDARY | Subject Satisfaction | 6 months | 1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants | participants satisfied | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Visible Surface Area | 1 Month post injection | All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma. | percentage change from baseline | MEAN |
| OTHER_PRE_SPECIFIED | Change in Visible Surface Area | 3 month post injection | All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma. | percentage change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Surface Area of the Lipoma at Six Months | AA4500 | -81.277 | Standard Deviation 22.9 | percentage change from baseline | |
| Percent Change From Baseline in Surface Area of the Lipoma at Six Months | Placebo | 2.053 | Standard Deviation 12.1 | percentage change from baseline | |
| Responder Analysis | AA4500 | 17 | participants | ||
| Responder Analysis | Placebo | 0 | participants | ||
| Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months | AA4500 | -64.1818 | Standard Deviation 28.97 | Percent change from baseline | |
| Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months | Placebo | 0.156 | Standard Deviation 7.78 | Percent change from baseline | |
| Subject Satisfaction | AA4500 | 18 | participants satisfied | ||
| Subject Satisfaction | Placebo | 7 | participants satisfied | ||
| Change in Visible Surface Area | AA4500 | -26.74 | Standard Deviation 35.57 | percentage change from baseline | |
| Change in Visible Surface Area | Placebo | 0.174 | Standard Deviation 8.38 | percentage change from baseline |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AA4500 and Placebo | 19 | |
| Overall Study | COMPLETED | AA4500 and Placebo | 19 | |
| Overall Study | NOT COMPLETED | AA4500 and Placebo | 0 |
Source ClinicalTrials.gov
Adverse events18
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 Bruising | General disorders | AA4500 | 17 | 19 | 17 |
| other | Injection site Bruising | General disorders | Placebo | 3 | 19 | 3 |
| other | Injection site swelling | General disorders | AA4500 | 15 | 19 | 15 |
| other | Injection site swelling | General disorders | Placebo | 0 | 19 | 0 |
| other | Injection site pain | General disorders | AA4500 | 10 | 19 | 10 |
| other | Injection site pain | General disorders | Placebo | 0 | 19 | 0 |
| other | Injection site pruritis | General disorders | AA4500 | 4 | 19 | 4 |
| other | Injection site pruritis | General disorders | Placebo | 0 | 19 | 0 |
| other | Injection site haemorrhage | General disorders | AA4500 | 2 | 19 | 2 |
| other | Injection site haemorrhage | General disorders | Placebo | 0 | 19 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AA4500 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AA4500 | 19 | 19 |
| Total, other adverse events | Placebo | 3 | 19 |
| Total, serious adverse events | AA4500 | 0 | 19 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AA4500 vs Placebo: Responder Analysis | Trial comparisons |
| AA4500 vs Placebo: serious adverse events | Trial comparisons |
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/NCT02249052
GET https://conductscience.org/api/trials/v1/NCT02249052/registered