Phase 2 Study for the Treatment of Superficial Lipomas

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Deoxycholic Acid 1%

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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

Deoxycholic Acid 2%

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.

Group Type EXPERIMENTAL

Deoxycholic Acid Injection

Intervention Type DRUG

Administered via intralipomal injection.

Deoxycholic Acid 4%

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.

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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching vehicle placebo administered via intralipomal injection.

Interventions

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Deoxycholic Acid Injection

Administered via intralipomal injection.

Intervention Type DRUG

Placebo

Matching vehicle placebo administered via intralipomal injection.

Intervention Type DRUG

Other Intervention Names

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sodium deoxycholate ATX-101

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No