Clinical trial · Interventional
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.
NCT01032889CI-TRIAL-00018266completedPhase 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)
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
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 |
|---|---|---|---|
| Moderate or Severe Submental Fullness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deoxycholic acid injection | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Deoxycholic acid Injection 1 mg/cm²
- description
- Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
- interventionNames
- Drug: Deoxycholic acid injection
- type
- EXPERIMENTAL
- label
- Deoxycholic acid Injection 2 mg/cm²
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Moderate or severe submental fat * Dissatisfaction with submental area * History of stable body weight * Signed informed consent Exclusion Criteria: * Any medical or other condition that would affect subject safety or evaluation of efficacy * Previous intervention in the submental area
References
Publications (0)
Data not yet available
No reference posted for this study.