Clinical trial · Interventional
Phase 2 Study for the Treatment of Superficial Lipomas
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
NCT00608842CI-TRIAL-00020535completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lipoma | Lipoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deoxycholic Acid Injection | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Deoxycholic Acid 1%
- description
- 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.
- interventionNames
- Drug: Deoxycholic Acid Injection
- type
- EXPERIMENTAL
- label
- Deoxycholic Acid 2%
- description
- 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.
- interventionNames
- Drug: Deoxycholic Acid Injection
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.