LipomaPhase 2NCT02249052
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
A Phase 2 study testing AA4500 in people with Lipoma, run by Gerut, Zachary, M.D. at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoma
- What is being tested?
- AA4500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age, of either sex or any race
- Clinical history of at least 2 lipomas for at least one year
- Lipomas diagnosed as benign
- Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges
- Each lipoma is a single mass with easily definable edges
- Lipomas are 5 to 24 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
- Multi-lobular lipomas
- Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study
- Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX
- Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment
Show all 9Show fewer
- Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments
- Subjects with a history of connective tissue diseases, rheumatological diseases
- Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aesthetic Center
Hewlett, New York, 11557
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Read the detailed description
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.
- Conditions
- Lipoma
- Being tested
- AA4500, placebo
- Medical subject headings
- Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA4500Drug
Also called XIAFLEX, Collagenase Clostridium Histolyticum
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AA4500 | Active comparator | single injection of 0.58 mg study drug Receives: Drug: AA4500 |
| Placebo | Placebo comparator | single injection of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months post injection
Secondary outcomes (3)
Responder Analysis
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
Measured: 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.
Measured: Baseline and 6 months
Subject Satisfaction
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionJun 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerut, Zachary, M.D.
- Collaborators
- Advance Biofactures Corporation
- Responsible party
- Sponsor
- Investigators
- Zachary E Gerut, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249052
- Sponsor's protocol ID
- 10-Lipoma II
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2014
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
- ClinicalTrials.gov ID
- NCT02249052
- Acronym / sponsor ID
- 10-Lipoma II
- Conditions
- Lipoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gerut, Zachary, M.D.
- Collaborators
- Advance Biofactures Corporation
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 13 Dec 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 study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA4500 | Active comparator | Drug: AA4500single injection of 0.58 mg study drug |
| Placebo | Placebo comparator | Drug: placebosingle injection of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years of age, of either sex or any race
- Clinical history of at least 2 lipomas for at least one year
- Lipomas diagnosed as benign
- Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges
- Each lipoma is a single mass with easily definable edges
Key exclusion criteria (9 listed)
- Lipomas on the head, neck, hand or foot, or female breast
- Women who are nursing or pregnant
- Multi-lobular lipomas
- Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study
- Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX
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 |
|---|---|---|
| AA4500Also: XIAFLEX, Collagenase Clostridium HistolyticumSubjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously | Drug | AA4500 |
| placeboPlacebo | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Surface Area of the Lipoma at Six Months
Time frame: 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.
3 secondary outcomes
Responder Analysis
Time frame: Baseline and 6 months
Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months
Time frame: Baseline and 6 months
Subject Satisfaction
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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, MD principal investigator
Private Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AA4500 in people with Lipoma, run by Gerut, Zachary, M.D. at 2 sites 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 7 inclusion and 9 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 13 Dec 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?
Percent Change From Baseline in Surface Area of the Lipoma at Six Months (time frame: Baseline and 6 months post injection). 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 23 Feb 2017.