Trial Outcomes & Findings for Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age (NCT NCT02123134)
NCT ID: NCT02123134
Last Updated: 2020-02-17
Results Overview
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
Baseline and up to Week 32 (12 weeks after last treatment)
Results posted on
2020-02-17
Participant Flow
A total of 55 subjects were randomized to either ATX-101 or placebo at a ratio of 1:1. A total of 28 subjects received ATX-101 and 26 subjects received placebo; 1 subject (803-003) was randomized to placebo but was not treated with placebo.
Participant milestones
| Measure |
ATX-101 (Deoxycholic Acid) Injection
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) 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 subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
ATX-101 (Deoxycholic Acid) Injection
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) 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 subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Overall Study
Withdrawal of consent
|
3
|
2
|
|
Overall Study
Administrative decision
|
0
|
1
|
Baseline Characteristics
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Baseline characteristics by cohort
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=28 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=27 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 2.76 • n=99 Participants
|
67.7 years
STANDARD_DEVIATION 2.30 • n=107 Participants
|
67.9 years
STANDARD_DEVIATION 2.53 • n=206 Participants
|
|
Age, Customized
65-69 years
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Customized
70-75 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
I
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
II
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
III
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
IV
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
V
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
VI
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Weight
|
77.44 kg
STANDARD_DEVIATION 14.170 • n=99 Participants
|
84.10 kg
STANDARD_DEVIATION 14.070 • n=107 Participants
|
80.71 kg
STANDARD_DEVIATION 14.388 • n=206 Participants
|
|
Body Mass Index (BMI)
|
29.27 kg/m^2
STANDARD_DEVIATION 4.207 • n=99 Participants
|
30.72 kg/m^2
STANDARD_DEVIATION 4.694 • n=107 Participants
|
29.98 kg/m^2
STANDARD_DEVIATION 4.471 • n=206 Participants
|
|
Body mass index category
Less than 30 kg/m^2
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Body mass index category
30 kg/m^2 or greater
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score
0
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score
1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score
2
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score
3
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score
4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
0
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
2
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
3
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score
4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Submental Skin Laxity Grade (SMSLG)
None
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Submental Skin Laxity Grade (SMSLG)
Mild
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Submental Skin Laxity Grade (SMSLG)
Moderate
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Submental Skin Laxity Grade (SMSLG)
Severe
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: Intent-to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
|
68.0 percentage of participants
Interval 49.7 to 86.3
|
25.0 percentage of participants
Interval 7.7 to 42.3
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
|
8.0 percentage of participants
Interval 0.0 to 18.6
|
4.2 percentage of participants
Interval 0.0 to 12.2
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
|
84.0 percentage of participants
Interval 69.6 to 98.4
|
41.7 percentage of participants
Interval 21.9 to 61.4
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
|
60.0 percentage of participants
Interval 40.8 to 79.2
|
12.5 percentage of participants
Interval 0.0 to 25.7
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
|
80.0 percentage of participants
Interval 64.3 to 95.7
|
45.8 percentage of participants
Interval 25.9 to 65.8
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
|
20.0 percentage of participants
Interval 4.3 to 35.7
|
20.8 percentage of participants
Interval 4.6 to 37.1
|
PRIMARY outcome
Timeframe: Baseline and up to Week 32 (12 weeks after last treatment)Population: ITT population included all randomized participants, whether or not they received the assigned study drug.
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=25 Participants
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=24 Participants
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
|
-0.5 scores on a scale
Standard Deviation 0.65
|
-0.1 scores on a scale
Standard Deviation 0.45
|
Adverse Events
ATX-101 (Deoxycholic Acid) Injection
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=28 participants at risk
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=26 participants at risk
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
Infections and infestations
Urosepsis
|
0.00%
0/28 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
3.8%
1/26 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
Other adverse events
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=28 participants at risk
Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
Placebo
n=26 participants at risk
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
|
|---|---|---|
|
General disorders
Injection site bruising
|
71.4%
20/28 • Number of events 42 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
57.7%
15/26 • Number of events 35 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site pain
|
71.4%
20/28 • Number of events 44 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
11.5%
3/26 • Number of events 6 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site swelling
|
60.7%
17/28 • Number of events 38 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
57.7%
15/26 • Number of events 54 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site anaesthesia
|
50.0%
14/28 • Number of events 16 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
0.00%
0/26 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site nodule
|
28.6%
8/28 • Number of events 8 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
11.5%
3/26 • Number of events 3 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site oedema
|
17.9%
5/28 • Number of events 14 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
0.00%
0/26 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site erythema
|
14.3%
4/28 • Number of events 9 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
11.5%
3/26 • Number of events 4 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
General disorders
Injection site induration
|
14.3%
4/28 • Number of events 7 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
0.00%
0/26 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
7.7%
2/26 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.1%
2/28 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
0.00%
0/26 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
7.7%
2/26 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
2/28 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
0.00%
0/26 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
7.1%
2/28 • Number of events 2 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
3.8%
1/26 • Number of events 1 • Up to 32 Weeks
Safety population included all randomized participants who received at least 1 injection of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER