Phase 2
N=73
Phase 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: NCT00618618 ↗Enrolled (actual)
73
Serious AEs
1.4%
Results posted
Jun 2015
Primary outcome: Primary: Number of Participants With Adverse Events — 24; 13; 20; 14 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
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
24; 13; 20; 14; 24; 13 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations |
3; 0; 2; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Submental Fat (SMF) Rating Scale Score |
-1.0; -1.2; -0.8; -0.4 | 0.005 sig |
| SECONDARY Change From Baseline in Subject Satisfaction With Appearance Rating Scale |
3.5; 4.3; 2.8; 1.8 | 0.005 sig |
| SECONDARY Percentage of Participants With a Response in the Subject Global Improvement Rating |
95.5; 90.0; 80.0; 57.1 | 0.008 sig |
| SECONDARY Percentage of Participants With an SMF Response |
81.8; 90.0; 60.0; 35.7 | 0.011 sig |
| SECONDARY Change From Baseline in Skin Laxity Rating |
-0.1; -0.1; -0.2; 0.0; -0.2; 0.1 | 0.460 |
| SECONDARY Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score |
-0.3; -0.5; -0.1; -0.3; -0.6; -0.6 | 0.934 |
| SECONDARY Change From Baseline in the Cervicomental Angle |
-5.0; -1.5; -1.5; -2.7 | 0.573 |
| SECONDARY Visual Analogue Scale Pain Intensity Rating |
33.0; 25.8; 41.9; 17.1; 27.9; 38.2 | — |
Summary
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
Eligibility Criteria
Inclusion Criteria
- Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (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 (NCT00618618). 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.