Phase 2
N=85
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Moderate or Severe Submental Fullness
Bottom Line
View on ClinicalTrials.gov: NCT00618722 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Number of Participants With Adverse Events — 20; 19; 22; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Deoxycholic Acid Injection (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
20; 19; 22; 21; 20; 19 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Submental Fat (SMF) Rating Scale Score |
-0.9; -0.8; -0.7; -0.5 | 0.043 sig |
| SECONDARY Change From Baseline in Subject Satisfaction With Appearance Rating Scale |
3.8; 3.3; 3.5; 1.9 | 0.003 sig |
| SECONDARY Percentage of Participants With a Response in the Subject Global Improvement Rating |
88.9; 78.9; 94.7; 50.0 | 0.015 sig |
| SECONDARY Change From Baseline in Skin Laxity Rating |
0.1; -0.1; 0.0; -0.2; 0.1; -0.1 | 0.078 |
| SECONDARY Change From Baseline in the Cervicomental Angle |
-0.7; 2.3; 6.9; -2.3 | 0.762 |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00618722). 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.