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Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

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ClinicalTrials.gov Identifier: NCT00422188
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Lipoma Drug: Deoxycholic Acid Injection Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • ATX-101
  • Sodium deoxycholate

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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • ATX-101
  • Sodium deoxycholate

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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • ATX-101
  • Sodium deoxycholate

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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • ATX-101
  • Sodium deoxycholate

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.
Drug: Placebo
Administered via intralipomal injection.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Lipoma size reduction [ Time Frame: up to 16 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422188


Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Principal Investigator: Stacy R. Smith, M.D. Therapeutics Clinical Research

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00422188     History of Changes
Other Study ID Numbers: ATX-101-06-04
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Lipoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents