A Phase 2 interventional study of AA4500 and placebo in Lipoma, sponsored by Gerut, Zachary, M.D.. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Gerut, Zachary, M.D. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's enrollment of 19 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →This is the only study on the registry with Gerut, Zachary, M.D. as lead sponsor.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
single injection of 0.58 mg study drug
Drug: AA4500
single injection of placebo
Drug: placebo
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
Also known as: XIAFLEX, Collagenase Clostridium Histolyticum
Placebo
Percent Change From Baseline in Surface Area of the Lipoma at Six Months
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.
Time frame: Baseline and 6 months post injection
Responder Analysis
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
Time frame: Baseline and 6 months
Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 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.
Time frame: Baseline and 6 months
Subject Satisfaction
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
Time frame: 6 months
Change in Visible Surface Area
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.
Time frame: 1 Month post injection
Change in Visible Surface Area
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.
Time frame: 3 month post injection
Subjects were screened and enrolled at two study sites in the United States.
| Milestone | AA4500 and Placebo |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| percentage change from baseline | AA4500 | Placebo |
|---|---|---|
| Percent Change From Baseline in Surface Area of the Lipoma at Six Months | -81.277 ± 22.9 | 2.053 ± 12.1 |
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
| participants | AA4500 | Placebo |
|---|---|---|
| Responder Analysis | 17 | 0 |
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.
| Percent change from baseline | AA4500 | Placebo |
|---|---|---|
| Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months | -64.1818 ± 28.97 | 0.156 ± 7.78 |
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
| participants satisfied | AA4500 | Placebo |
|---|---|---|
| Subject Satisfaction | 18 | 7 |
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.
| percentage change from baseline | AA4500 | Placebo |
|---|---|---|
| Change in Visible Surface Area | -26.74 ± 35.57 | 0.174 ± 8.38 |
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.
| percentage change from baseline | AA4500 | Placebo |
|---|---|---|
| Change in Visible Surface Area | -62.51 ± 32.14 | 0.402 ± 12.92 |
Collected over 6 months post administration study medication. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AA4500 | — | 0/19 (0%) | 19/19 (100%) |
| Placebo | — | 0/19 (0%) | 3/19 (15.8%) |
| Event | AA4500 | Placebo |
|---|---|---|
| Injection site BruisingGeneral disorders | 17/19 | 3/19 |
| Injection site swellingGeneral disorders | 15/19 | 0/19 |
| Injection site painGeneral disorders | 10/19 | 0/19 |
| Injection site pruritisGeneral disorders | 4/19 | 0/19 |
| Injection site haemorrhageGeneral disorders | 2/19 | 0/19 |
| Skin disorderSkin and subcutaneous tissue disorders | 2/19 | 0/19 |
| Injection site discolourationGeneral disorders | 1/19 | 0/19 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/19 | 0/19 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 1/19 | 0/19 |
| Age, Continuous(years) | AA4500 and Placebo |
|---|---|
| Mean | 49.9 ± 9.13 |
| Gender(Participants) | AA4500 and Placebo |
|---|---|
| Female | 4 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | AA4500 and Placebo |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Aug 2014, a primary completion of Apr 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2016, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Microbial Collagenase