Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
- Conditions
- Moderate or Severe Submental Fullness
- Interventions
- Drug: Placebo
- Registration Number
- NCT01032889
- Lead Sponsor
- Kythera Biopharmaceuticals
- Brief Summary
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Moderate or severe submental fat
- Dissatisfaction with submental area
- History of stable body weight
- Signed informed consent
- Any medical or other condition that would affect subject safety or evaluation of efficacy
- Previous intervention in the submental area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Deoxycholic acid Injection 1 mg/cm² Deoxycholic acid injection 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. Deoxycholic acid Injection 2 mg/cm² Deoxycholic acid injection Participants received deoxycholic acid 2 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Submental Fat Volume Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) Submental fat volume was measured by magnetic resonance imaging (MRI).
Change From Baseline in Submental Fat Thickness Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) Submental fat thickness was measured by magnetic resonance imaging (MRI).
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Plano, Texas, United States