- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422188
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
December 8, 2015 updated by: Kythera Biopharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92123
- Therapeutics Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deoxycholic Acid Injection 0.5%
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.
|
Administered via intralipomal injection.
Other Names:
|
Experimental: Deoxycholic Acid Injection 1.0%
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.
|
Administered via intralipomal injection.
Other Names:
|
Experimental: Deoxycholic Acid Injection 2.0%
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.
|
Administered via intralipomal injection.
Other Names:
|
Experimental: Deoxycholic Acid Injection 4.0%
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.
|
Administered via intralipomal injection.
Other Names:
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Placebo Comparator: Placebo
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.
|
Administered via intralipomal injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessments of Safety with Laboratory tests
Time Frame: up to 16 weeks
|
up to 16 weeks
|
Assessments of Safety with ECG
Time Frame: up to 16 weeks
|
up to 16 weeks
|
Assessments of Safety with Medical Evaluations
Time Frame: up to 16 weeks
|
up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lipoma size reduction
Time Frame: up to 16 weeks
|
up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stacy R. Smith, M.D., Therapeutics Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
January 11, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Estimate)
December 10, 2015
Last Update Submitted That Met QC Criteria
December 8, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATX-101-06-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Kythera BiopharmaceuticalsCompletedModerate or Severe Submental FullnessAustralia, Canada, United Kingdom
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Kythera BiopharmaceuticalsBayerCompletedModerate or Severe Submental FullnessBelgium, France, Germany, Italy, Spain, United Kingdom
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Kythera BiopharmaceuticalsCompletedModerate or Severe Submental FullnessUnited States
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Kythera BiopharmaceuticalsCompleted