Phase 2
N=62
Phase 2 Study for the Treatment of Superficial Lipomas
Lipoma
Bottom Line
View on ClinicalTrials.gov: NCT00608842 ↗Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Jan 2016
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 12; 13; 14; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Deoxycholic Acid Injection (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
12; 13; 14; 12; 6; 9 | — |
| PRIMARY Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs or Weight |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Positive Histopathology Results at Screening |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Positive Histopathology Results at Week 20 |
3; 2; 1; 0; 10; 12 | — |
| SECONDARY Percentage of Participants With Complete Clearance or ≥ 75% Clearance |
0.0; 0.0; 7.1; 0.0; 13.3; 6.7 | — |
| SECONDARY Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas |
41.2; 28.5; 18.0; 38.5; 43.9; 23.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00608842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.