Clinical trial · Interventional
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
NCT00618618CI-TRIAL-00018528completedPhase 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)
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath 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 (6)
- type
- EXPERIMENTAL
- label
- Deoxycholic Acid Injection 0.2 mL/0.7 cm
- description
- Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
- interventionNames
- Drug: Deoxycholic Acid Injection
- type
- PLACEBO_COMPARATOR
- label
- Placebo 0.2 mL/0.7 cm
- description
- Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale * Good general health * Signed informed consent Exclusion Criteria: * History of any treatment in the neck or chin area * Loose skin or prominent platysmal bands in the neck or chin area * Recent treatment with anticoagulants * Presence of clinically significant health problems
References
Publications (0)
Data not yet available
No reference posted for this study.