NCT00422188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

January 11, 2007

Last Update Submit

December 8, 2015

Conditions

Lipoma

Outcome Measures

Primary Outcomes (3)

  • Assessments of Safety with Laboratory tests

    up to 16 weeks

  • Assessments of Safety with ECG

    up to 16 weeks

  • Assessments of Safety with Medical Evaluations

    up to 16 weeks

Secondary Outcomes (1)

  • Lipoma size reduction

    up to 16 weeks

Study Arms (5)

Deoxycholic Acid Injection 0.5%

EXPERIMENTAL

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

Deoxycholic Acid Injection 1.0%

EXPERIMENTAL

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

Deoxycholic Acid Injection 2.0%

EXPERIMENTAL

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

Deoxycholic Acid Injection 4.0%

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Deoxycholic Acid InjectionDRUG

Administered via intralipomal injection.

Also known as: ATX-101, Sodium deoxycholate
Deoxycholic Acid Injection 0.5%Deoxycholic Acid Injection 1.0%Deoxycholic Acid Injection 2.0%Deoxycholic Acid Injection 4.0%
PlaceboDRUG

Administered via intralipomal injection.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Lipoma

Interventions

Deoxycholic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Cholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Stacy R. Smith, M.D.

    Therapeutics Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

US(1)