Conditions: Moderate or Severe Submental Fullness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

Brief summary:
To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

Detailed description:
The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Arms:
arm 1: Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 4: Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Interventions: intervention 1: Deoxycholic Acid Injection intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: