A Phase 2 interventional study of Collagenase Clostridium Histolyticum in Lipoma, sponsored by Zachary Gerut. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by Zachary Gerut · Phase 2, Interventional, and Treatment
The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). 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.
Lipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the general adult population. They usually present as painful or annoying lumps that are palpable and often visible in the subcutaneous tissue. Many subcutaneous lipomas are asymptomatic and are removed for non-medical reasons. However, they may cause the subject pain or discomfort or interfere with normal activity.
Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself, remains there for the lifetime of a person who carries it and may stay small or become larger. Alternative treatments of the lipoma are surgery or liposuction. If a large excision is performed there is the problem of having a very large scar and the accompanying issues of healing a large scar, or possible formation of a hematoma followed by consolidation of the hematoma and the remnants of a mass of scar tissue. This is often painful and more problematic than the original lipoma. liposuction also has the potential for hematoma formation followed by scar mass residual.
To avoid the complications listed above, a non-invasive method of treatment, such as enzyme mediated disassociation of adipose tissue, would be desirable. The primary aim of this study is to perform a step-wise approach in dosing to evaluate the safety and efficacy of clostridium histolyticum as a non-operative treatment for lipoma.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's enrollment of 14 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 Zachary Gerut as lead sponsor.
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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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single injection 0.058 mg Collagenase Clostridium Histolyticum
Drug: Collagenase Clostridium Histolyticum
single injection 0.15 mg Collagenase Clostridium Histolyticum
Drug: Collagenase Clostridium Histolyticum
single injection 0.29 mg Collagenase Clostridium Histolyticum
Drug: Collagenase Clostridium Histolyticum
single injection 0.44 mg Collagenase Clostridium Histolyticum
Drug: Collagenase Clostridium Histolyticum
This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
Also known as: XIAFLEX
Change in Visible Surface Area of the Lipoma
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.
Time frame: Baseline and Six months post injection of study drug
Relative Change in Volume of the Lipoma
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.
Time frame: Baseline and 6 months post injection of study drug
Subjects were screened and enrolled at 1 site in the United States
| Milestone | Dose #1 | Dose #2 | Dose #3 | Dose #4 |
|---|---|---|---|---|
| Started | 2 | 4 | 4 | 4 |
| Completed | 2 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Percent change from baseline | Dose #1 | Dose #2 | Dose #3 | Dose #4 |
|---|---|---|---|---|
| Change in Visible Surface Area of the Lipoma | -31.69 ± 80.83 | -47.57 ± 23.48 | -52.42 ± 50.61 | -66.60 ± 17.82 |
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.
| Percent reduction from baseline | Dose #1 | Dose #2 | Dose #3 | Dose #4 |
|---|---|---|---|---|
| Relative Change in Volume of the Lipoma | -54.16 ± 34.3 | -62.33 ± 30.39 | -11.35 ± 32.12 | -34.75 ± 24.21 |
Collected over Adverse Events were collected from Day 0 through 6 months post administration of study medication. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose #1 | — | 0/2 (0%) | 1/2 (50%) |
| Dose #2 | — | 0/4 (0%) | 3/4 (75%) |
| Dose #3 | — | 0/4 (0%) | 3/4 (75%) |
| Dose #4 | — | 0/4 (0%) | 4/4 (100%) |
| Event | Dose #1 | Dose #2 | Dose #3 | Dose #4 |
|---|---|---|---|---|
| BruisingGeneral disorders | 1/2 | 3/4 | 3/4 | 4/4 |
| PainGeneral disorders | 0/2 | 3/4 | 1/4 | 3/4 |
| SwellingGeneral disorders | 0/2 | 0/4 | 3/4 | 1/4 |
| ContusionVascular disorders | 0/2 | 1/4 | 0/4 | 0/4 |
| HeadacheNervous system disorders | 0/2 | 0/4 | 1/4 | 0/4 |
| NauseaGastrointestinal disorders | 0/2 | 0/4 | 1/4 | 0/4 |
| DizzinessCardiac disorders | 0/2 | 0/4 | 1/4 | 0/4 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 0/2 | 0/4 | 1/4 | 0/4 |
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 0/2 | 0/4 | 1/4 | 0/4 |
| Age, Continuous(Years) | Dose #1 | Dose #2 | Dose #3 | Dose #4 | Total |
|---|---|---|---|---|---|
| Mean | 48.0 ± 5.66 | 51.5 ± 12.50 | 41.3 ± 11.09 | 57.0 ± 4.97 | 49.6 ± 10.60 |
| Sex: Female, Male(Participants) | Dose #1 | Dose #2 | Dose #3 | Dose #4 | Total |
|---|---|---|---|---|---|
| Female | 2 | 3 | 3 | 1 | 9 |
| Male | 0 | 1 | 1 | 3 | 5 |
| Region of Enrollment(participants) | Dose #1 | Dose #2 | Dose #3 | Dose #4 | Total |
|---|---|---|---|---|---|
| United States | 2 | 4 | 4 | 4 | 14 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of May 2012, a primary completion of Sep 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 2 years 6 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