Phase 3
N=84
Patient Experience Study of Deoxycholic Acid Injection
Moderate or Severe Submental Fullness
Bottom Line
View on ClinicalTrials.gov: NCT02007434 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Change From Baseline in Pain Visual Analog Scale Scores — 0.0; 0.0; 0.0; 0.0 units on a scale — p=0.6803
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Deoxycholic Acid Injection (Drug); Placebo (Drug); Cold Compress (Other); Lidocaine / Epinephrine (Drug); Loratadine (Drug); Ibuprofen (Drug); Compression Chin Strap (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Visual Analog Scale Scores |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.6803 |
| PRIMARY Change From Baseline in Pain Assessment Using McGill Pain Questionnaire |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Swelling Grading Scale Scores |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Bruising Grading Scale Scores |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Induration Grading Scale Scores |
0.0; 0.0; 0.1; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) |
-0.6; -0.7; -0.6; -0.8; -0.4; 0.0 | — |
| SECONDARY Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) |
-1.2; -0.7; -0.9; -0.5; -0.8; -0.8 | — |
| SECONDARY Change From Baseline in Subject Self Rating Scale (SSRS) |
2.8; 2.3; 3.2; 1.8; 2.3; 2.3 | — |
| SECONDARY Change From Baseline in Submental Skin Laxity Grades (SMSLG) |
0.2; 0.0; 0.1; 0.5; 0.3; 0.5 | — |
| SECONDARY Change From Baseline in Submental Fat Thickness |
-1.4; -2.3; -1.6; -0.3; -0.9; -2.3 | — |
| SECONDARY Patient Experience Questions |
81; 33; 81; 50; 94; 100 | — |
Summary
The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
Eligibility Criteria
Inclusion Criteria
- Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
- Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
- History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
- Acceptable skin laxity as determined by the investigator
- Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
- Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
- Signed informed consent obtained before any study-specific procedure is performed.
Exclusion Criteria
- No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
- Absence of clinically significant health problems
- Body mass index > 40.0 kg/m² as determined prior to randomization.
- History of drug or alcohol abuse.
Data sourced from ClinicalTrials.gov (NCT02007434). 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.