Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the 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
Arms & Interventions
Deoxycholic Acid Injection 1 mg/cm²
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.
Intervention: Deoxycholic Acid Injection (Drug)
Deoxycholic acid Injection 2 mg/cm²
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.
Intervention: Deoxycholic Acid Injection (Drug)
Deoxycholic acid Injection 4 mg/cm²
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.
Intervention: Deoxycholic Acid Injection (Drug)
Placebo
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Time Frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Secondary Outcomes
- Change From Baseline in Submental Fat (SMF) Rating Scale Score(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Change From Baseline in Subject Satisfaction With Appearance Rating Scale(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Change From Baseline in Skin Laxity Rating(Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment))
- Percentage of Participants With a Response in the Subject Global Improvement Rating(4 weeks after last treatment (up to 16 weeks after first dose))
- Change From Baseline in the Cervicomental Angle(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))