Phase 2 Study for the Treatment of Superficial Lipomas

NCT00608842 | Completed Phase 2 Results

• 1 other identifier: ATX-101-07-05
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Lipoma

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events (AEs)

  Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.

  Up to 24 weeks

• Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities

  An abnormality is defined as a value outside the limits of the expanded normal range/notable range.

  24 weeks

• Number of Participants With Clinically Significant Changes in Vital Signs or Weight

  Up to 24 weeks

• Number of Participants With Positive Histopathology Results at Screening

  A needle core tissue sample biopsy was performed at screening for all treated lipomas.

  Screening (prior to randomization)

• Number of Participants With Positive Histopathology Results at Week 20

  After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.

  Week 20

Secondary Outcomes (2)

• Percentage of Participants With Complete Clearance or ≥ 75% Clearance

  Baseline and week 20 (8 weeks after last dose)

• Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas

  Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)

Study Arms (4)

Deoxycholic Acid 1%

EXPERIMENTAL

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.

Drug: Deoxycholic Acid Injection

Deoxycholic Acid 2%

EXPERIMENTAL

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.

Drug: Deoxycholic Acid Injection

Deoxycholic Acid 4%

EXPERIMENTAL

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.

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

Drug: Placebo

Interventions

Deoxycholic Acid Injection DRUG

Administered via intralipomal injection.

Also known as: sodium deoxycholate, ATX-101

Deoxycholic Acid 1%; Deoxycholic Acid 2%; Deoxycholic Acid 4%

Placebo DRUG

Matching vehicle placebo administered via intralipomal injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (7)

Gary D. Monheit, M.D.

Birmingham, Alabama, 35205, United States

Location

Stacy R. Smith

San Diego, California, 92123, United States

Location

Steven Grekin, D.O.

Warren, Michigan, 48088, United States

Location

Joel Schlessinger, M.D.

Omaha, Nebraska, 68144, United States

Location

David J. Goldberg, M.D.

Westwood, New Jersey, 07675, United States

Location

Neil S. Sadick, M.D.

New York, New York, 10021, United States

Location

Michael H. Gold, M.D.

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Lipoma

Interventions

Deoxycholic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Kythera Biopharmaceuticals, Inc.

clinical_trials@kythera.com

Study Officials

• Patricia S. Walker, M.D., Ph.D.

  Kythera Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2010
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (7)