Phase 2
N=129
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Moderate or Severe Submental Fullness
Bottom Line
View on ClinicalTrials.gov: NCT01032889 ↗Enrolled (actual)
129
Serious AEs
0.8%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores — -0.7; -0.8; -0.4 units on a scale — p=0.052
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Deoxycholic acid injection (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores |
-0.7; -0.8; -0.4 | 0.052 |
| PRIMARY Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) |
-0.9; -1.3; -0.7 | 0.117 |
| PRIMARY Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) |
-3.5; -4.5; -2.1 | 0.005 sig |
| SECONDARY Change From Baseline in Submental Fat Volume |
-614; -118; -8.1 | 0.166 |
| SECONDARY Change From Baseline in Submental Fat Thickness |
-1.8; -1.9; -0.3 | <0.001 sig |
Summary
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01032889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.