Trial Outcomes & Findings for Patient Experience Study of Deoxycholic Acid Injection (NCT NCT02007434)
NCT ID: NCT02007434
Last Updated: 2015-07-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
Baseline and Day 84
Results posted on
2015-07-28
Participant Flow
This study was performed at one investigational center in the United States (US).
Participant milestones
| Measure |
Paradigm 1 / Deoxycholic Acid Injection
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale \[CR-SMFRS\] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
4
|
17
|
4
|
16
|
4
|
18
|
4
|
|
Overall Study
Received Treatment
|
17
|
3
|
17
|
4
|
16
|
4
|
18
|
4
|
|
Overall Study
COMPLETED
|
16
|
3
|
16
|
4
|
16
|
4
|
18
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Paradigm 1 / Deoxycholic Acid Injection
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale \[CR-SMFRS\] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
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
Patient Experience Study of Deoxycholic Acid Injection
Baseline characteristics by cohort
| Measure |
Paradigm 1 / Deoxycholic Acid Injection
n=17 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=17 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 14.05 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 13.08 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 11.67 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 11.48 • n=21 Participants
|
44.8 years
STANDARD_DEVIATION 14.84 • n=8 Participants
|
42.3 years
STANDARD_DEVIATION 13.08 • n=8 Participants
|
48.0 years
STANDARD_DEVIATION 8.64 • n=24 Participants
|
43.5 years
STANDARD_DEVIATION 12.07 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
15 participants
n=5 Participants
|
1 participants
n=7 Participants
|
13 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
3 participants
n=8 Participants
|
14 participants
n=8 Participants
|
4 participants
n=24 Participants
|
66 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
0 participants
n=24 Participants
|
12 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
|
Weight
|
191.01 pounds
STANDARD_DEVIATION 40.086 • n=5 Participants
|
221.00 pounds
STANDARD_DEVIATION 34.492 • n=7 Participants
|
205.61 pounds
STANDARD_DEVIATION 38.716 • n=5 Participants
|
223.90 pounds
STANDARD_DEVIATION 27.534 • n=4 Participants
|
205.74 pounds
STANDARD_DEVIATION 32.847 • n=21 Participants
|
217.90 pounds
STANDARD_DEVIATION 11.485 • n=8 Participants
|
200.30 pounds
STANDARD_DEVIATION 36.592 • n=8 Participants
|
185.05 pounds
STANDARD_DEVIATION 68.356 • n=24 Participants
|
202.53 pounds
STANDARD_DEVIATION 37.514 • n=42 Participants
|
|
Body Mass Index (BMI)
|
30.959 kg/m²
STANDARD_DEVIATION 4.2723 • n=5 Participants
|
28.867 kg/m²
STANDARD_DEVIATION 4.9923 • n=7 Participants
|
33.206 kg/m²
STANDARD_DEVIATION 4.9806 • n=5 Participants
|
33.350 kg/m²
STANDARD_DEVIATION 3.1586 • n=4 Participants
|
32.763 kg/m²
STANDARD_DEVIATION 3.7764 • n=21 Participants
|
36.850 kg/m²
STANDARD_DEVIATION 2.3587 • n=8 Participants
|
31.706 kg/m²
STANDARD_DEVIATION 3.3457 • n=8 Participants
|
31.250 kg/m²
STANDARD_DEVIATION 7.7229 • n=24 Participants
|
32.266 kg/m²
STANDARD_DEVIATION 4.3474 • n=42 Participants
|
|
Fitzpatrick Skin Type
I-III
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
2 participants
n=8 Participants
|
6 participants
n=8 Participants
|
1 participants
n=24 Participants
|
36 participants
n=42 Participants
|
|
Fitzpatrick Skin Type
IV-VI
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
2 participants
n=8 Participants
|
12 participants
n=8 Participants
|
3 participants
n=24 Participants
|
47 participants
n=42 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
2
|
13 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
4 participants
n=8 Participants
|
15 participants
n=8 Participants
|
2 participants
n=24 Participants
|
58 participants
n=42 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
3
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
25 participants
n=42 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
2
|
10 participants
n=5 Participants
|
2 participants
n=7 Participants
|
14 participants
n=5 Participants
|
1 participants
n=4 Participants
|
12 participants
n=21 Participants
|
1 participants
n=8 Participants
|
13 participants
n=8 Participants
|
3 participants
n=24 Participants
|
56 participants
n=42 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
3
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=8 Participants
|
5 participants
n=8 Participants
|
1 participants
n=24 Participants
|
27 participants
n=42 Participants
|
|
Subject Self Rating Scale (SSRS)
0
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
7 participants
n=42 Participants
|
|
Subject Self Rating Scale (SSRS)
1
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
3 participants
n=8 Participants
|
8 participants
n=8 Participants
|
1 participants
n=24 Participants
|
43 participants
n=42 Participants
|
|
Subject Self Rating Scale (SSRS)
2
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
1 participants
n=8 Participants
|
10 participants
n=8 Participants
|
2 participants
n=24 Participants
|
33 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at both time points
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).
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pain Visual Analog Scale Scores
|
0.0 units on a scale
Interval 0.0 to 2.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
0.0 units on a scale
Interval -1.0 to 1.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
0.0 units on a scale
Interval -2.0 to 5.0
|
0.0 units on a scale
Interval 0.0 to 0.0
|
0.0 units on a scale
Interval -2.0 to 1.0
|
0.0 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline (predose) and Day 84Population: Safety analysis set with available data at both time points
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).
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Punishing-Cruel
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Present pain
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Throbbing
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Shooting
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Stabbing
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Sharp
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Cramping
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Gnawing
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Hot-Burning
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Heavy
|
0.1 units on a scale
Standard Deviation 0.25
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Splitting
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Tiring-Exhausting
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Sickening
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Fearful
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Aching
|
0.1 units on a scale
Standard Deviation 0.25
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Tender
|
0.1 units on a scale
Standard Deviation 0.25
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.1 units on a scale
Standard Deviation 0.25
|
0.0 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 84Population: Safety analysis set with available data
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)
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Swelling Grading Scale Scores
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 84Population: Safety analysis set with available data
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)
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Bruising Grading Scale Scores
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 84Population: Safety analysis set with available data
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)
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Induration Grading Scale Scores
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.1 units on a scale
Standard Deviation 0.32
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
0.1 units on a scale
Standard Deviation 0.25
|
0.0 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at each time point.
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.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
|
-0.4 units on a scale
Standard Deviation 0.50
|
0.0 units on a scale
Standard Deviation 0.82
|
-0.4 units on a scale
Standard Deviation 0.50
|
-0.3 units on a scale
Standard Deviation 0.50
|
-0.6 units on a scale
Standard Deviation 0.50
|
-0.7 units on a scale
Standard Deviation 0.58
|
-0.6 units on a scale
Standard Deviation 0.63
|
-0.8 units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at both time points
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.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
|
-0.8 units on a scale
Standard Deviation 0.86
|
-0.8 units on a scale
Standard Deviation 0.50
|
-0.7 units on a scale
Standard Deviation 0.57
|
-0.5 units on a scale
Standard Deviation 0.58
|
-1.2 units on a scale
Standard Deviation 0.75
|
-0.7 units on a scale
Standard Deviation 1.15
|
-0.9 units on a scale
Standard Deviation 0.72
|
-0.5 units on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at both time points
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.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Subject Self Rating Scale (SSRS)
|
2.3 units on a scale
Standard Deviation 1.95
|
2.3 units on a scale
Standard Deviation 1.50
|
2.4 units on a scale
Standard Deviation 1.38
|
2.0 units on a scale
Standard Deviation 1.41
|
2.8 units on a scale
Standard Deviation 1.84
|
2.3 units on a scale
Standard Deviation 3.51
|
3.2 units on a scale
Standard Deviation 1.56
|
1.8 units on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at both time points
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.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Submental Skin Laxity Grades (SMSLG)
|
0.3 units on a scale
Standard Deviation 0.45
|
0.5 units on a scale
Standard Deviation 0.58
|
0.3 units on a scale
Standard Deviation 0.67
|
0.3 units on a scale
Standard Deviation 0.50
|
0.2 units on a scale
Standard Deviation 0.66
|
0.0 units on a scale
Standard Deviation 0.00
|
0.1 units on a scale
Standard Deviation 0.77
|
0.5 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Safety analysis set with available data at both time points
Submental thickness was measured using caliper devices.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Submental Fat Thickness
|
-0.9 mm
Standard Deviation 3.77
|
-2.3 mm
Standard Deviation 2.22
|
-1.5 mm
Standard Deviation 3.33
|
-2.8 mm
Standard Deviation 2.22
|
-1.4 mm
Standard Deviation 1.67
|
-2.3 mm
Standard Deviation 2.08
|
-1.6 mm
Standard Deviation 2.34
|
-0.3 mm
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Day 84Population: Safety analysis set with available data at each time point
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.
Outcome measures
| Measure |
Paradigm 3 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 3 / Placebo
n=4 Participants
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 Participants
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.
|
Paradigm 4 / Placebo
n=4 Participants
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.
|
Paradigm 1 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 1 / Placebo
n=3 Participants
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=16 Participants
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.
|
Paradigm 2 / Placebo
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Patient Experience Questions
Normal Activity Affected
|
19 percentage of participants
|
0 percentage of participants
|
11 percentage of participants
|
25 percentage of participants
|
13 percentage of participants
|
0 percentage of participants
|
13 percentage of participants
|
0 percentage of participants
|
|
Patient Experience Questions
Recommend to a Friend
|
94 percentage of participants
|
100 percentage of participants
|
72 percentage of participants
|
75 percentage of participants
|
81 percentage of participants
|
33 percentage of participants
|
81 percentage of participants
|
50 percentage of participants
|
|
Patient Experience Questions
Receive Additional Treatments
|
94 percentage of participants
|
100 percentage of participants
|
78 percentage of participants
|
100 percentage of participants
|
81 percentage of participants
|
67 percentage of participants
|
88 percentage of participants
|
50 percentage of participants
|
Adverse Events
Paradigm 1 / Deoxycholic Acid Injection
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Paradigm 1 / Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Paradigm 2 / Deoxycholic Acid Injection
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Paradigm 2 / Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Paradigm 3 / Deoxycholic Acid Injection
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Paradigm 3 / Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Paradigm 4 / Deoxycholic Acid Injection
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Paradigm 4 / Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paradigm 1 / Deoxycholic Acid Injection
n=17 participants at risk
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.
|
Paradigm 1 / Placebo
n=3 participants at risk
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.
|
Paradigm 2 / Deoxycholic Acid Injection
n=17 participants at risk
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.
|
Paradigm 2 / Placebo
n=4 participants at risk
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.
|
Paradigm 3 / Deoxycholic Acid Injection
n=16 participants at risk
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.
|
Paradigm 3 / Placebo
n=4 participants at risk
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.
|
Paradigm 4 / Deoxycholic Acid Injection
n=18 participants at risk
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.
|
Paradigm 4 / Placebo
n=4 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Application site alopecia
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Fatigue
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site anaesthesia
|
5.9%
1/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site discomfort
|
76.5%
13/17 • 84 days
|
0.00%
0/3 • 84 days
|
82.4%
14/17 • 84 days
|
0.00%
0/4 • 84 days
|
68.8%
11/16 • 84 days
|
25.0%
1/4 • 84 days
|
44.4%
8/18 • 84 days
|
50.0%
2/4 • 84 days
|
|
General disorders
Injection site dysaesthesia
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site erythema
|
11.8%
2/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site haematoma
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site haemorrhage
|
100.0%
17/17 • 84 days
|
33.3%
1/3 • 84 days
|
88.2%
15/17 • 84 days
|
75.0%
3/4 • 84 days
|
100.0%
16/16 • 84 days
|
100.0%
4/4 • 84 days
|
94.4%
17/18 • 84 days
|
100.0%
4/4 • 84 days
|
|
General disorders
Injection site induration
|
100.0%
17/17 • 84 days
|
0.00%
0/3 • 84 days
|
94.1%
16/17 • 84 days
|
25.0%
1/4 • 84 days
|
100.0%
16/16 • 84 days
|
25.0%
1/4 • 84 days
|
100.0%
18/18 • 84 days
|
75.0%
3/4 • 84 days
|
|
General disorders
Injection site nodule
|
5.9%
1/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site oedema
|
100.0%
17/17 • 84 days
|
66.7%
2/3 • 84 days
|
100.0%
17/17 • 84 days
|
100.0%
4/4 • 84 days
|
100.0%
16/16 • 84 days
|
100.0%
4/4 • 84 days
|
100.0%
18/18 • 84 days
|
100.0%
4/4 • 84 days
|
|
General disorders
Injection site pain
|
100.0%
17/17 • 84 days
|
66.7%
2/3 • 84 days
|
100.0%
17/17 • 84 days
|
25.0%
1/4 • 84 days
|
100.0%
16/16 • 84 days
|
50.0%
2/4 • 84 days
|
100.0%
18/18 • 84 days
|
50.0%
2/4 • 84 days
|
|
General disorders
Injection site pruritus
|
17.6%
3/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
General disorders
Injection site rash
|
5.9%
1/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
25.0%
1/4 • 84 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Infections and infestations
Viral infection
|
5.9%
1/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
25.0%
1/4 • 84 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
25.0%
1/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
5.9%
1/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • 84 days
|
0.00%
0/3 • 84 days
|
11.8%
2/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
16.7%
3/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.8%
2/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
5.6%
1/18 • 84 days
|
25.0%
1/4 • 84 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
6.2%
1/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
5.9%
1/17 • 84 days
|
0.00%
0/3 • 84 days
|
0.00%
0/17 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/16 • 84 days
|
0.00%
0/4 • 84 days
|
0.00%
0/18 • 84 days
|
0.00%
0/4 • 84 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.
- Publication restrictions are in place
Restriction type: OTHER