LipomaPhase 2NCT01613313
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
A Phase 2 study testing Collagenase Clostridium Histolyticum in people with Lipoma, run by Zachary Gerut at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lipoma
- What is being tested?
- Collagenase Clostridium Histolyticum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history lipoma at least one year and no treatment within last 90 days
- Lipoma diagnosed as benign
- Lipoma is a single mass with easily definable edges
- Lipoma has an area of 2.0 to 17 cm squared
- Women of childbearing potential must use an acceptable method of birth control
Who cannot join
- Lipomas on the head, neck, hand or foot, or female breast
- Women who are nursing or pregnant
- Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study
- Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX
- Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment.
- Subjects having a history of trauma in the area of the lipoma
Show all 13Show fewer
- Subjects with a history of connective tissue diseases or rheumatological diseases.
- Subjects with uncontrolled hypertension
- Subjects currently receiving or planning to receive anticoagulant medication except for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days before injection of study drug
- Subjects having the following laboratory abnormalities:
- ALT/AST greater than 3 times the upper limit of normal
- Creatinine greater than 2
- Hemoglobin/hematocrit and WBC outside the normal range
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Lipoma
- Being tested
- Collagenase Clostridium Histolyticum
- Keywords
- Lipoma, Fatty Tumor
- Medical subject headings
- Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium HistolyticumDrug
Also called XIAFLEX
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose #1 | Experimental | single injection 0.058 mg Collagenase Clostridium Histolyticum Receives: Drug: Collagenase Clostridium Histolyticum |
| Dose #2 | Experimental | single injection 0.15 mg Collagenase Clostridium Histolyticum Receives: Drug: Collagenase Clostridium Histolyticum |
| Dose #3 | Experimental | single injection 0.29 mg Collagenase Clostridium Histolyticum Receives: Drug: Collagenase Clostridium Histolyticum |
| Dose #4 | Experimental | single injection 0.44 mg Collagenase Clostridium Histolyticum Receives: Drug: Collagenase Clostridium Histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Six months post injection of study drug
Secondary outcomes (1)
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.
Measured: Baseline and 6 months post injection of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zachary Gerut
- Collaborators
- Advance Biofactures Corporation
- Responsible party
- Sponsor-investigator, Zachary Gerut, Gerut, Zachary, M.D.
- Investigators
- Zachary E Gerut, M.D., Principal investigator, Gerut, Zachary, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613313
- Sponsor's protocol ID
- Lipoma DE/01
- Status last verified
- Aug 2016
- First submitted
- 5 Jun 2012
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
- ClinicalTrials.gov ID
- NCT01613313
- Acronym / sponsor ID
- Lipoma DE/01
- Conditions
- Lipoma
- Keywords
- Lipoma, Fatty Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Zachary Gerut
- Collaborators
- Advance Biofactures Corporation
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 9 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose #1 | Experimental | Drug: Collagenase Clostridium Histolyticumsingle injection 0.058 mg Collagenase Clostridium Histolyticum |
| Dose #2 | Experimental | Drug: Collagenase Clostridium Histolyticumsingle injection 0.15 mg Collagenase Clostridium Histolyticum |
| Dose #3 | Experimental | Drug: Collagenase Clostridium Histolyticumsingle injection 0.29 mg Collagenase Clostridium Histolyticum |
| Dose #4 | Experimental | Drug: Collagenase Clostridium Histolyticumsingle injection 0.44 mg Collagenase Clostridium Histolyticum |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical history lipoma at least one year and no treatment within last 90 days
- Lipoma diagnosed as benign
- Lipoma is a single mass with easily definable edges
- Lipoma has an area of 2.0 to 17 cm squared
- Women of childbearing potential must use an acceptable method of birth control
Key exclusion criteria (13 listed)
- Lipomas on the head, neck, hand or foot, or female breast
- Women who are nursing or pregnant
- Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study
- Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX
- Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium HistolyticumAlso: XIAFLEXThis 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. | Drug | Dose #1, Dose #2, Dose #3, Dose #4 |
Primary outcome
Change in Visible Surface Area of the Lipoma
Time frame: 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.
1 secondary outcome
Relative Change in Volume of the Lipoma
Time frame: Baseline and 6 months post injection of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary E Gerut, M.D. principal investigator
Gerut, Zachary, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagenase Clostridium Histolyticum in people with Lipoma, run by Zachary Gerut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visible Surface Area of the Lipoma (time frame: Baseline and Six months post injection of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.