Moderate or Severe Submental Fullness
Conditions
Brief 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.
Detailed description
This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms. Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
Interventions
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUGPlacebo
Phosphate buffered saline placebo for injection
OTHERCold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
DRUGLidocaine / Epinephrine
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
DRUGLoratadine
Loratadine 10 mg orally from Day -7 until Day 7
DRUGIbuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
OTHERCompression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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) 2. 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) 3. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m². 4. Acceptable skin laxity as determined by the investigator 5. 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. 6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair) 7. Signed informed consent obtained before any study-specific procedure is performed.
Exclusion criteria
1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area 2. Absence of clinically significant health problems 3. Body mass index \> 40.0 kg/m² as determined prior to randomization. 4. History of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Visual Analog Scale Scores | Baseline and Day 84 | Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible). |
| Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Baseline (predose) and Day 84 | Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating). |
| Swelling Grading Scale Scores | Day 84 | The following grading system was used for the assessment of swelling: * Swelling/edema absent (0) * Minimal swelling/edema contained within treatment area (1) * Modest swelling/edema contained within treatment area (2) * Substantial swelling/edema contained within treatment area (3) * Swelling/edema of the neck and face beyond the treatment area (4) |
| Bruising Grading Scale Scores | Day 84 | The following grading system was used for the assessment of bruising: * Bruising absent (0) * Bruising associated with 1 to 3 needle insertion points (1) * Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2) * Bruising covering the entire treatment area but contained within the treatment area (3) * Bruising of the neck and face beyond the treatment area (4) |
| Induration Grading Scale Scores | Day 84 | The following grading system was used for the assessment of induration: * Induration absent to minimal (0) * Induration associated with at least approximately 30% of the treatment area (1) * Induration associated with greater than approximately 30% to at least 60% of the treatment area (2) * Induration covering the entire treatment area but contained within the treatment area (3) * Induration of the neck and face beyond the treatment area (4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline and Day 84 | 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. |
| Patient Experience Questions | Day 84 | Participants were asked to complete 3 patient experience questions, each answered as Yes or No: Given your experience in this study: 1. Would you recommend this procedure to a friend? 2. Would you agree to receive additional treatments? 3. Has the treatment you received in this study affected your normal activities? The percentage of participants answering Yes on each question is reported. |
| Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline and Day 84 | 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 Subject Self Rating Scale (SSRS) | Baseline and Day 84 | The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement. |
| Change From Baseline in Submental Skin Laxity Grades (SMSLG) | Baseline and Day 84 | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement. |
| Change From Baseline in Submental Fat Thickness | Baseline and Day 84 | Submental thickness was measured using caliper devices. |
Countries
United States
Participant flow
Recruitment details
This study was performed at one investigational center in the United States (US).
Participants by arm
| Arm | Count |
|---|---|
| Paradigm 1 / Deoxycholic Acid Injection Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. | 17 |
| Paradigm 1 / Placebo Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. | 3 |
| Paradigm 2 / Deoxycholic Acid Injection Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. | 17 |
| Paradigm 2 / Placebo Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. | 4 |
| Paradigm 3 / Deoxycholic Acid Injection Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. | 16 |
| Paradigm 3 / Placebo Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 4 |
| Paradigm 4 / Deoxycholic Acid Injection Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 18 |
| Paradigm 4 / Placebo Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 4 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Non-compliance | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Paradigm 1 / Placebo | Paradigm 1 / Deoxycholic Acid Injection | Total | Paradigm 4 / Placebo | Paradigm 4 / Deoxycholic Acid Injection | Paradigm 3 / Placebo | Paradigm 3 / Deoxycholic Acid Injection | Paradigm 2 / Placebo | Paradigm 2 / Deoxycholic Acid Injection |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 14.05 | 47.8 years STANDARD_DEVIATION 11.08 | 43.5 years STANDARD_DEVIATION 12.07 | 48.0 years STANDARD_DEVIATION 8.64 | 42.3 years STANDARD_DEVIATION 13.08 | 44.8 years STANDARD_DEVIATION 14.84 | 41.3 years STANDARD_DEVIATION 11.48 | 43.8 years STANDARD_DEVIATION 11.67 | 42.4 years STANDARD_DEVIATION 13.08 |
| Body Mass Index (BMI) | 28.867 kg/m² STANDARD_DEVIATION 4.9923 | 30.959 kg/m² STANDARD_DEVIATION 4.2723 | 32.266 kg/m² STANDARD_DEVIATION 4.3474 | 31.250 kg/m² STANDARD_DEVIATION 7.7229 | 31.706 kg/m² STANDARD_DEVIATION 3.3457 | 36.850 kg/m² STANDARD_DEVIATION 2.3587 | 32.763 kg/m² STANDARD_DEVIATION 3.7764 | 33.350 kg/m² STANDARD_DEVIATION 3.1586 | 33.206 kg/m² STANDARD_DEVIATION 4.9806 |
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 2 | 1 participants | 13 participants | 58 participants | 2 participants | 15 participants | 4 participants | 9 participants | 2 participants | 12 participants |
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 3 | 2 participants | 4 participants | 25 participants | 2 participants | 3 participants | 0 participants | 7 participants | 2 participants | 5 participants |
| Fitzpatrick Skin Type I-III | 0 participants | 12 participants | 36 participants | 1 participants | 6 participants | 2 participants | 6 participants | 2 participants | 7 participants |
| Fitzpatrick Skin Type IV-VI | 3 participants | 5 participants | 47 participants | 3 participants | 12 participants | 2 participants | 10 participants | 2 participants | 10 participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 2 | 2 participants | 10 participants | 56 participants | 3 participants | 13 participants | 1 participants | 12 participants | 1 participants | 14 participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 3 | 1 participants | 7 participants | 27 participants | 1 participants | 5 participants | 3 participants | 4 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 12 participants | 0 participants | 3 participants | 1 participants | 2 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 1 participants | 15 participants | 66 participants | 4 participants | 14 participants | 3 participants | 12 participants | 4 participants | 13 participants |
| Sex: Female, Male Female | 1 Participants | 12 Participants | 51 Participants | 3 Participants | 9 Participants | 3 Participants | 10 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 32 Participants | 1 Participants | 9 Participants | 1 Participants | 6 Participants | 2 Participants | 6 Participants |
| Subject Self Rating Scale (SSRS) 0 | 1 participants | 1 participants | 7 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants | 3 participants |
| Subject Self Rating Scale (SSRS) 1 | 1 participants | 8 participants | 43 participants | 1 participants | 8 participants | 3 participants | 10 participants | 3 participants | 9 participants |
| Subject Self Rating Scale (SSRS) 2 | 1 participants | 8 participants | 33 participants | 2 participants | 10 participants | 1 participants | 5 participants | 1 participants | 5 participants |
| Weight | 221.00 pounds STANDARD_DEVIATION 34.492 | 191.01 pounds STANDARD_DEVIATION 40.086 | 202.53 pounds STANDARD_DEVIATION 37.514 | 185.05 pounds STANDARD_DEVIATION 68.356 | 200.30 pounds STANDARD_DEVIATION 36.592 | 217.90 pounds STANDARD_DEVIATION 11.485 | 205.74 pounds STANDARD_DEVIATION 32.847 | 223.90 pounds STANDARD_DEVIATION 27.534 | 205.61 pounds STANDARD_DEVIATION 38.716 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 17 | 3 / 3 | 17 / 17 | 4 / 4 | 16 / 16 | 4 / 4 | 18 / 18 | 4 / 4 |
| serious Total, serious adverse events | 0 / 17 | 0 / 3 | 0 / 17 | 0 / 4 | 0 / 16 | 0 / 4 | 0 / 18 | 0 / 4 |
Outcome results
Primary
Bruising Grading Scale Scores
The following grading system was used for the assessment of bruising: * Bruising absent (0) * Bruising associated with 1 to 3 needle insertion points (1) * Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2) * Bruising covering the entire treatment area but contained within the treatment area (3) * Bruising of the neck and face beyond the treatment area (4)
Time frame: Day 84
Population: Safety analysis set with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Bruising Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
Primary
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).
Time frame: Baseline (predose) and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.1 units on a scale | Standard Deviation 0.25 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.1 units on a scale | Standard Deviation 0.25 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.1 units on a scale | Standard Deviation 0.25 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.1 units on a scale | Standard Deviation 0.25 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Aching | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Heavy | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Gnawing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tender | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Cramping | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Splitting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Shooting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Tiring-Exhausting | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sharp | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Sickening | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Fearful | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Stabbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Hot-Burning | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Punishing-Cruel | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Throbbing | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Present pain | 0.0 units on a scale | Standard Deviation 0 |
Primary
Change From Baseline in Pain Visual Analog Scale Scores
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 1 / Placebo | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 2 / Placebo | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 3 / Placebo | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
| Paradigm 4 / Placebo | Change From Baseline in Pain Visual Analog Scale Scores | 0.0 units on a scale |
Comparison: Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.680395% CI: [-0.93, 1.41]ANCOVA
Comparison: Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.520695% CI: [-0.82, 1.6]ANCOVA
Comparison: Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.606395% CI: [-0.86, 1.46]ANCOVA
Comparison: Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.793595% CI: [-0.98, 1.27]ANCOVA
Comparison: Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.91495% CI: [-1.03, 1.15]ANCOVA
Comparison: Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.p-value: 0.875495% CI: [-1.21, 1.04]ANCOVA
Primary
Induration Grading Scale Scores
The following grading system was used for the assessment of induration: * Induration absent to minimal (0) * Induration associated with at least approximately 30% of the treatment area (1) * Induration associated with greater than approximately 30% to at least 60% of the treatment area (2) * Induration covering the entire treatment area but contained within the treatment area (3) * Induration of the neck and face beyond the treatment area (4)
Time frame: Day 84
Population: Safety analysis set with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Induration Grading Scale Scores | 0.1 units on a scale | Standard Deviation 0.25 |
| Paradigm 2 / Placebo | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Induration Grading Scale Scores | 0.1 units on a scale | Standard Deviation 0.32 |
| Paradigm 4 / Placebo | Induration Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
Primary
Swelling Grading Scale Scores
The following grading system was used for the assessment of swelling: * Swelling/edema absent (0) * Minimal swelling/edema contained within treatment area (1) * Modest swelling/edema contained within treatment area (2) * Substantial swelling/edema contained within treatment area (3) * Swelling/edema of the neck and face beyond the treatment area (4)
Time frame: Day 84
Population: Safety analysis set with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 1 / Placebo | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Placebo | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Deoxycholic Acid Injection | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 3 / Placebo | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Deoxycholic Acid Injection | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 4 / Placebo | Swelling Grading Scale Scores | 0.0 units on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
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.
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.6 units on a scale | Standard Deviation 0.5 |
| Paradigm 1 / Placebo | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.7 units on a scale | Standard Deviation 0.58 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.6 units on a scale | Standard Deviation 0.63 |
| Paradigm 2 / Placebo | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.8 units on a scale | Standard Deviation 0.96 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.4 units on a scale | Standard Deviation 0.5 |
| Paradigm 3 / Placebo | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 0.0 units on a scale | Standard Deviation 0.82 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.4 units on a scale | Standard Deviation 0.5 |
| Paradigm 4 / Placebo | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | -0.3 units on a scale | Standard Deviation 0.5 |
Secondary
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
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.
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -1.2 units on a scale | Standard Deviation 0.75 |
| Paradigm 1 / Placebo | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.7 units on a scale | Standard Deviation 1.15 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.9 units on a scale | Standard Deviation 0.72 |
| Paradigm 2 / Placebo | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.5 units on a scale | Standard Deviation 1.29 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.8 units on a scale | Standard Deviation 0.86 |
| Paradigm 3 / Placebo | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.8 units on a scale | Standard Deviation 0.5 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.7 units on a scale | Standard Deviation 0.57 |
| Paradigm 4 / Placebo | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | -0.5 units on a scale | Standard Deviation 0.58 |
Secondary
Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.8 units on a scale | Standard Deviation 1.84 |
| Paradigm 1 / Placebo | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.3 units on a scale | Standard Deviation 3.51 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Subject Self Rating Scale (SSRS) | 3.2 units on a scale | Standard Deviation 1.56 |
| Paradigm 2 / Placebo | Change From Baseline in Subject Self Rating Scale (SSRS) | 1.8 units on a scale | Standard Deviation 1.71 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.3 units on a scale | Standard Deviation 1.95 |
| Paradigm 3 / Placebo | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.3 units on a scale | Standard Deviation 1.5 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.4 units on a scale | Standard Deviation 1.38 |
| Paradigm 4 / Placebo | Change From Baseline in Subject Self Rating Scale (SSRS) | 2.0 units on a scale | Standard Deviation 1.41 |
Secondary
Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices.
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Submental Fat Thickness | -1.4 mm | Standard Deviation 1.67 |
| Paradigm 1 / Placebo | Change From Baseline in Submental Fat Thickness | -2.3 mm | Standard Deviation 2.08 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Submental Fat Thickness | -1.6 mm | Standard Deviation 2.34 |
| Paradigm 2 / Placebo | Change From Baseline in Submental Fat Thickness | -0.3 mm | Standard Deviation 2.75 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Submental Fat Thickness | -0.9 mm | Standard Deviation 3.77 |
| Paradigm 3 / Placebo | Change From Baseline in Submental Fat Thickness | -2.3 mm | Standard Deviation 2.22 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Submental Fat Thickness | -1.5 mm | Standard Deviation 3.33 |
| Paradigm 4 / Placebo | Change From Baseline in Submental Fat Thickness | -2.8 mm | Standard Deviation 2.22 |
Secondary
Change From Baseline in Submental Skin Laxity Grades (SMSLG)
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Population: Safety analysis set with available data at both time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.2 units on a scale | Standard Deviation 0.66 |
| Paradigm 1 / Placebo | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.0 units on a scale | Standard Deviation 0 |
| Paradigm 2 / Deoxycholic Acid Injection | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.1 units on a scale | Standard Deviation 0.77 |
| Paradigm 2 / Placebo | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.5 units on a scale | Standard Deviation 0.58 |
| Paradigm 3 / Deoxycholic Acid Injection | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.3 units on a scale | Standard Deviation 0.45 |
| Paradigm 3 / Placebo | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.5 units on a scale | Standard Deviation 0.58 |
| Paradigm 4 / Deoxycholic Acid Injection | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.3 units on a scale | Standard Deviation 0.67 |
| Paradigm 4 / Placebo | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | 0.3 units on a scale | Standard Deviation 0.5 |
Secondary
Patient Experience Questions
Participants were asked to complete 3 patient experience questions, each answered as Yes or No: Given your experience in this study: 1. Would you recommend this procedure to a friend? 2. Would you agree to receive additional treatments? 3. Has the treatment you received in this study affected your normal activities? The percentage of participants answering Yes on each question is reported.
Time frame: Day 84
Population: Safety analysis set with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Patient Experience Questions | Recommend to a Friend | 81 percentage of participants |
| Paradigm 1 / Deoxycholic Acid Injection | Patient Experience Questions | Normal Activity Affected | 13 percentage of participants |
| Paradigm 1 / Deoxycholic Acid Injection | Patient Experience Questions | Receive Additional Treatments | 81 percentage of participants |
| Paradigm 1 / Placebo | Patient Experience Questions | Normal Activity Affected | 0 percentage of participants |
| Paradigm 1 / Placebo | Patient Experience Questions | Receive Additional Treatments | 67 percentage of participants |
| Paradigm 1 / Placebo | Patient Experience Questions | Recommend to a Friend | 33 percentage of participants |
| Paradigm 2 / Deoxycholic Acid Injection | Patient Experience Questions | Normal Activity Affected | 13 percentage of participants |
| Paradigm 2 / Deoxycholic Acid Injection | Patient Experience Questions | Recommend to a Friend | 81 percentage of participants |
| Paradigm 2 / Deoxycholic Acid Injection | Patient Experience Questions | Receive Additional Treatments | 88 percentage of participants |
| Paradigm 2 / Placebo | Patient Experience Questions | Recommend to a Friend | 50 percentage of participants |
| Paradigm 2 / Placebo | Patient Experience Questions | Receive Additional Treatments | 50 percentage of participants |
| Paradigm 2 / Placebo | Patient Experience Questions | Normal Activity Affected | 0 percentage of participants |
| Paradigm 3 / Deoxycholic Acid Injection | Patient Experience Questions | Receive Additional Treatments | 94 percentage of participants |
| Paradigm 3 / Deoxycholic Acid Injection | Patient Experience Questions | Recommend to a Friend | 94 percentage of participants |
| Paradigm 3 / Deoxycholic Acid Injection | Patient Experience Questions | Normal Activity Affected | 19 percentage of participants |
| Paradigm 3 / Placebo | Patient Experience Questions | Receive Additional Treatments | 100 percentage of participants |
| Paradigm 3 / Placebo | Patient Experience Questions | Recommend to a Friend | 100 percentage of participants |
| Paradigm 3 / Placebo | Patient Experience Questions | Normal Activity Affected | 0 percentage of participants |
| Paradigm 4 / Deoxycholic Acid Injection | Patient Experience Questions | Receive Additional Treatments | 78 percentage of participants |
| Paradigm 4 / Deoxycholic Acid Injection | Patient Experience Questions | Recommend to a Friend | 72 percentage of participants |
| Paradigm 4 / Deoxycholic Acid Injection | Patient Experience Questions | Normal Activity Affected | 11 percentage of participants |
| Paradigm 4 / Placebo | Patient Experience Questions | Recommend to a Friend | 75 percentage of participants |
| Paradigm 4 / Placebo | Patient Experience Questions | Receive Additional Treatments | 100 percentage of participants |
| Paradigm 4 / Placebo | Patient Experience Questions | Normal Activity Affected | 25 percentage of participants |