LipomaPhase 2NCT00608842
Phase 2 Study for the Treatment of Superficial Lipomas
A Phase 2 study testing Deoxycholic Acid Injection in people with Lipoma, run by Kythera Biopharmaceuticals at 7 sites in United States.
Trial summary
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lipoma
- What is being tested?
- Deoxycholic Acid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2007to Jan 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- History of slow growth followed by dormancy, and stable for at least 6 months
- Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
- Located on the trunk, arms, legs, or neck
- Signed informed consent.
Who cannot join
- Absence of significant medical conditions that could affect safety
- History of surgical or deoxycholate treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Gary D. Monheit, M.D.
Birmingham, Alabama, 35205
Michael H. Gold, M.D.
Nashville, Tennessee, 37215
Neil S. Sadick, M.D.
New York, New York, 10021
Joel Schlessinger, M.D.
Omaha, Nebraska, 68144
Stacy R. Smith
San Diego, California, 92123
Steven Grekin, D.O.
Warren, Michigan, 48088
David J. Goldberg, M.D.
Westwood, New Jersey, 07675
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
Read the detailed description
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
- Conditions
- Lipoma
- Being tested
- Deoxycholic Acid Injection, Placebo
- Medical subject headings
- Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deoxycholic Acid InjectionDrug
Also called sodium deoxycholate, ATX-101
Administered via intralipomal injection.
PlaceboDrug
Matching vehicle placebo administered via intralipomal injection.
| Study group | Role | What they receive |
|---|---|---|
| Deoxycholic Acid 1% | Experimental | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Deoxycholic Acid 2% | Experimental | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Deoxycholic Acid 4% | Experimental | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Placebo | Placebo comparator | Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Severity of AEs was determined using the following scale:
Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Measured: Up to 24 weeks
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Measured: 24 weeks
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Measured: Up to 24 weeks
Number of Participants With Positive Histopathology Results at Screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Measured: Screening (prior to randomization)
Number of Participants With Positive Histopathology Results at Week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
Measured: Week 20
Secondary outcomes (2)
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.
Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).
For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response.
Measured: Baseline and week 20 (8 weeks after last dose)
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size.
Measured: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionJan 2010
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia S. Walker, M.D., Ph.D., Study director, Kythera Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608842
- Sponsor's protocol ID
- ATX-101-07-05
- Status last verified
- Dec 2015
- First submitted
- 23 Jan 2008
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
- ClinicalTrials.gov ID
- NCT00608842
- Acronym / sponsor ID
- ATX-101-07-05
- Conditions
- Lipoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 14 Jan 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 compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
Detailed description
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Deoxycholic Acid 1% | Experimental | Drug: Deoxycholic Acid InjectionParticipants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| Deoxycholic Acid 2% | Experimental | Drug: Deoxycholic Acid InjectionParticipants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| Deoxycholic Acid 4% | Experimental | Drug: Deoxycholic Acid InjectionParticipants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- Signed informed consent.
Key exclusion criteria (3 listed)
- Absence of significant medical conditions that could affect safety
- History of surgical or deoxycholate treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 treatment
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 |
|---|---|---|
| Deoxycholic Acid InjectionAlso: sodium deoxycholate, ATX-101Administered via intralipomal injection. | Drug | Deoxycholic Acid 1%, Deoxycholic Acid 2%, Deoxycholic Acid 4% |
| PlaceboMatching vehicle placebo administered via intralipomal injection. | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 24 weeks
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Time frame: 24 weeks
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Time frame: Up to 24 weeks
Number of Participants With Positive Histopathology Results at Screening
Time frame: Screening (prior to randomization)
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Number of Participants With Positive Histopathology Results at Week 20
Time frame: Week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
2 secondary outcomes
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
Time frame: Baseline and week 20 (8 weeks after last dose)
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Time frame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patricia S. Walker, M.D., Ph.D. study director
Kythera Biopharmaceuticals, Inc.
7 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 Deoxycholic Acid Injection in people with Lipoma, run by Kythera Biopharmaceuticals at 7 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 3 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 14 Jan 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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 24 weeks). The study lists 5 primary outcomes in all. 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 14 Jan 2016.