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OpenTrials
Completed

NCT Number: NCT00422188

Deoxycholic Acid Injection 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.

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Key information

Conditions

Lipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Therapeutics Clinical Research

San Diego, California, 92123, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deoxycholic acid Injection

Drug

Administered via intralipomal injection.

Other names: ATX-101, Sodium deoxycholate

Placebo

Drug

Administered via intralipomal injection.

Primary outcomes

  1. Assessments of Safety with Laboratory tests

    Time frame: up to 16 weeks

  2. Assessments of Safety with ECG

    Time frame: up to 16 weeks

  3. Assessments of Safety with Medical Evaluations

    Time frame: up to 16 weeks

Secondary outcomes

  1. Lipoma size reduction

    Time frame: up to 16 weeks

Sponsors and collaborators

Lead sponsor

Kythera Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2007
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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