LipomaPhase 1NCT00422188
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
A Phase 1 study testing Deoxycholic Acid Injection in people with Lipoma, run by Kythera Biopharmaceuticals at 1 site in United States.
Trial summary
The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 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 by greatest perpendicular width between 1 and 16 square centimeters, inclusive
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Located on the trunk, arms, legs, or neck
- Stable body weight with a body mass index of less than 30 kg/m²
- Signed informed consent
Who cannot join
- Absence of significant medical conditions that could affect safety
- History of surgical treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, 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 4 different concentrations of deoxycholic acid 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 ATX-101, Sodium deoxycholate
Administered via intralipomal injection.
PlaceboDrug
Administered via intralipomal injection.
| Study group | Role | What they receive |
|---|---|---|
| Deoxycholic Acid Injection 0.5% | Experimental | Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. Receives: Drug: Deoxycholic Acid Injection |
| Deoxycholic Acid Injection 1.0% | Experimental | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. Receives: Drug: Deoxycholic Acid Injection |
| Deoxycholic Acid Injection 2.0% | Experimental | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. Receives: Drug: Deoxycholic Acid Injection |
| Deoxycholic Acid Injection 4.0% | Experimental | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. 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 5 mL for 2 treatments at 28-day intervals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of Safety with Laboratory tests
Measured: up to 16 weeks
Assessments of Safety with ECG
Measured: up to 16 weeks
Assessments of Safety with Medical Evaluations
Measured: up to 16 weeks
Secondary outcomes (1)
Lipoma size reduction
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacy R. Smith, M.D., Principal investigator, Therapeutics Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422188
- Sponsor's protocol ID
- ATX-101-06-04
- Status last verified
- Dec 2015
- First submitted
- 11 Jan 2007
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
- ClinicalTrials.gov ID
- NCT00422188
- Acronym / sponsor ID
- ATX-101-06-04
- Conditions
- Lipoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
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 4 different concentrations of deoxycholic acid 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
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Deoxycholic Acid Injection 0.5% | Experimental | Drug: Deoxycholic Acid InjectionParticipants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. |
| Deoxycholic Acid Injection 1.0% | 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 5 mL for 2 treatments at 28-day intervals. |
| Deoxycholic Acid Injection 2.0% | 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 5 mL for 2 treatments at 28-day intervals. |
| Deoxycholic Acid Injection 4.0% | 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 5 mL for 2 treatments at 28-day intervals. |
| 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 5 mL for 2 treatments at 28-day intervals. |
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 diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- Stable body weight with a body mass index of less than 30 kg/m²
- Signed informed consent
Key exclusion criteria (3 listed)
- Absence of significant medical conditions that could affect safety
- History of surgical 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: ATX-101, Sodium deoxycholateAdministered via intralipomal injection. | Drug | Deoxycholic Acid Injection 0.5%, Deoxycholic Acid Injection 1.0%, Deoxycholic Acid Injection 2.0%, Deoxycholic Acid Injection 4.0% |
| PlaceboAdministered via intralipomal injection. | Drug | Placebo |
Primary outcome
Assessments of Safety with Laboratory tests
Time frame: up to 16 weeks
Assessments of Safety with ECG
Time frame: up to 16 weeks
Assessments of Safety with Medical Evaluations
Time frame: up to 16 weeks
1 secondary outcome
Lipoma size reduction
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
Stacy R. Smith, M.D. principal investigator
Therapeutics Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deoxycholic Acid Injection in people with Lipoma, run by Kythera Biopharmaceuticals 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 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 10 Dec 2015. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessments of Safety with Laboratory tests (time frame: up to 16 weeks). The study lists 3 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 10 Dec 2015.