Trial Outcomes & Findings for Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study (NCT NCT01032889)
NCT ID: NCT01032889
Last Updated: 2015-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Results posted on
2015-06-15
Participant Flow
This study was conducted at 10 centers in the United States.
Participant milestones
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
45
|
|
Overall Study
Received Treatment
|
41
|
43
|
45
|
|
Overall Study
COMPLETED
|
33
|
28
|
42
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
3
|
Reasons for withdrawal
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
|
Overall Study
Withdrawal of Consent
|
1
|
2
|
1
|
|
Overall Study
Patient Request
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Lack of Submental Fat
|
2
|
8
|
1
|
|
Overall Study
Miscellaneous Reasons
|
2
|
1
|
1
|
Baseline Characteristics
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Baseline characteristics by cohort
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=41 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=43 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 9.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
38 participants
n=5 Participants
|
35 participants
n=7 Participants
|
36 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Weight
|
84.88 kg
STANDARD_DEVIATION 15.835 • n=5 Participants
|
89.32 kg
STANDARD_DEVIATION 21.225 • n=7 Participants
|
87.78 kg
STANDARD_DEVIATION 16.059 • n=5 Participants
|
87.39 kg
STANDARD_DEVIATION 17.851 • n=4 Participants
|
|
Body Mass Index (BMI)
|
29.68 kg/m²
STANDARD_DEVIATION 4.845 • n=5 Participants
|
31.48 kg/m²
STANDARD_DEVIATION 6.633 • n=7 Participants
|
30.85 kg/m²
STANDARD_DEVIATION 5.315 • n=5 Participants
|
30.70 kg/m²
STANDARD_DEVIATION 5.665 • n=4 Participants
|
|
Fitzpatrick Skin Type
I - III
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
33 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
Fitzpatrick Skin Type
IV - VI
|
11 participants
n=5 Participants
|
17 participants
n=7 Participants
|
12 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating
2
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
18 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating
3
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
27 participants
n=5 Participants
|
72 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data.
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 |
Deoxycholic Acid Injection 1 mg/cm²
n=40 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=42 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores
|
-0.7 units on a scale
Interval -0.9 to -0.45
|
-0.8 units on a scale
Interval -1.06 to -0.62
|
-0.4 units on a scale
Interval -0.58 to -0.16
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.
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 |
Deoxycholic Acid Injection 1 mg/cm²
n=37 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=39 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=43 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
|
-0.9 units on a scale
Interval -1.17 to -0.72
|
-1.3 units on a scale
Interval -1.53 to -1.09
|
-0.7 units on a scale
Interval -0.91 to -0.49
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.
The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=39 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=40 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=44 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
|
-3.5 units on a scale
Interval -4.21 to -2.78
|
-4.5 units on a scale
Interval -5.25 to -3.81
|
-2.1 units on a scale
Interval -2.73 to -1.37
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Modified intent-to-treat population; LOCF method was used to impute missing data.
Submental fat volume was measured by magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=40 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=42 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Change From Baseline in Submental Fat Volume
|
-614 mm³
Interval -1093.0 to -136.0
|
-118 mm³
Interval -644.0 to 407.0
|
-8.1 mm³
Interval -742.0 to 725.7
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)Population: Modified intent-to-treat population; LOCF method was used to impute missing data.
Submental fat thickness was measured by magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=40 Participants
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=42 Participants
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 Participants
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Change From Baseline in Submental Fat Thickness
|
-1.8 mm
Interval -2.37 to -1.19
|
-1.9 mm
Interval -2.51 to -1.35
|
-0.3 mm
Interval -0.83 to 0.29
|
Adverse Events
Deoxycholic Acid Injection 1 mg/cm²
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Deoxycholic Acid Injection 2 mg/cm²
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=41 participants at risk
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=43 participants at risk
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 participants at risk
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
2.3%
1/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
0.00%
0/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
Other adverse events
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=41 participants at risk
Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=43 participants at risk
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=45 participants at risk
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|---|
|
General disorders
Injection site anesthesia
|
63.4%
26/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
60.5%
26/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
8.9%
4/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site discomfort
|
7.3%
3/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
4.7%
2/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
0.00%
0/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site edema
|
46.3%
19/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
37.2%
16/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
28.9%
13/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site erythema
|
36.6%
15/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
27.9%
12/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
31.1%
14/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site hematoma
|
56.1%
23/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
48.8%
21/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
68.9%
31/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site hemorrhage
|
7.3%
3/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
2.3%
1/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
15.6%
7/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site induration
|
26.8%
11/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
32.6%
14/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
11.1%
5/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site nodule
|
12.2%
5/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
9.3%
4/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
4.4%
2/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site pain
|
70.7%
29/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
53.5%
23/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
28.9%
13/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site paresthesia
|
17.1%
7/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
9.3%
4/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
6.7%
3/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site pruritus
|
26.8%
11/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
25.6%
11/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
6.7%
3/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
General disorders
Injection site swelling
|
39.0%
16/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
39.5%
17/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
11.1%
5/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
6/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
9.3%
4/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
15.6%
7/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
1/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
2.3%
1/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
6.7%
3/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
0.00%
0/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
0.00%
0/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
11.6%
5/43 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
13.3%
6/45 • From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
|
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