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Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

NCT ID: NCT00422188

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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

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Lipoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered via intralipomal injection.

Interventions

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Deoxycholic Acid Injection

Administered via intralipomal injection.

Intervention Type DRUG

Placebo

Administered via intralipomal injection.

Intervention Type DRUG

Other Intervention Names

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ATX-101 Sodium deoxycholate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kythera Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacy R. Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

Therapeutics Clinical Research

Locations

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Therapeutics Clinical Research

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ATX-101-06-04

Identifier Type: -

Identifier Source: org_study_id