Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat (NCT NCT01294644)
NCT ID: NCT01294644
Last Updated: 2015-06-12
Results Overview
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
360 participants
Primary outcome timeframe
Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Results posted on
2015-06-12
Participant Flow
The study was conducted at 29 study centers in the European Union.
The study consisted of a 12-week treatment period and a 12-week safety follow-up period.
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 4 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 4 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 4 treatments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
122
|
117
|
|
Overall Study
Received Treatment
|
118
|
122
|
114
|
|
Overall Study
COMPLETED
|
111
|
112
|
103
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
14
|
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 4 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 4 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 4 treatments.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
5
|
|
Overall Study
Miscellaneous Reason
|
2
|
1
|
4
|
Baseline Characteristics
Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Baseline characteristics by cohort
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=118 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=114 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 4 treatments.
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 9.87 • n=4 Participants
|
|
Age, Customized
18 - 50 years
|
74 participants
n=5 Participants
|
80 participants
n=7 Participants
|
75 participants
n=5 Participants
|
229 participants
n=4 Participants
|
|
Age, Customized
51 - 65 years
|
44 participants
n=5 Participants
|
42 participants
n=7 Participants
|
39 participants
n=5 Participants
|
125 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
111 participants
n=5 Participants
|
114 participants
n=7 Participants
|
104 participants
n=5 Participants
|
329 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Weight
|
75.69 kg
STANDARD_DEVIATION 10.892 • n=5 Participants
|
75.60 kg
STANDARD_DEVIATION 10.913 • n=7 Participants
|
74.62 kg
STANDARD_DEVIATION 11.879 • n=5 Participants
|
75.32 kg
STANDARD_DEVIATION 11.205 • n=4 Participants
|
|
Body Mass Index (BMI)
|
26.26 kg/m²
STANDARD_DEVIATION 2.709 • n=5 Participants
|
26.53 kg/m²
STANDARD_DEVIATION 2.673 • n=7 Participants
|
26.06 kg/m²
STANDARD_DEVIATION 2.550 • n=5 Participants
|
26.29 kg/m²
STANDARD_DEVIATION 2.646 • n=4 Participants
|
|
Fitzpatrick Skin Type
I-III
|
99 participants
n=5 Participants
|
97 participants
n=7 Participants
|
91 participants
n=5 Participants
|
287 participants
n=4 Participants
|
|
Fitzpatrick Skin Type
IV-VI
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
23 participants
n=5 Participants
|
67 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. 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.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=120 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=116 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 4 treatments.
|
|---|---|---|---|
|
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
|
58.3 percentage of participants
|
62.3 percentage of participants
|
34.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population; LOCF method was used to impute missing data
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. 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.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=120 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=116 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 4 treatments.
|
|---|---|---|---|
|
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
|
68.3 percentage of participants
|
64.8 percentage of participants
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population; LOCF method was used to impute missing data
A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment. 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.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=120 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=116 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 4 treatments.
|
|---|---|---|---|
|
Percentage of Participants With a CR-SMFRS 2-grade Response
|
9.2 percentage of participants
|
9.0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population with available 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=111 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=112 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 4 treatments
|
Placebo
n=103 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 4 treatments.
|
|---|---|---|---|
|
Change From Baseline in CR-SMFRS Score
|
-0.7 units on a scale
Standard Deviation 0.64
|
-0.8 units on a scale
Standard Deviation 0.61
|
-0.4 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population with available data
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 |
Deoxycholic Acid Injection 1 mg/cm²
n=111 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=111 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 4 treatments
|
Placebo
n=103 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 4 treatments.
|
|---|---|---|---|
|
Change From Baseline in SSRS Scores
|
2.9 units on a scale
Standard Deviation 1.61
|
2.9 units on a scale
Standard Deviation 1.53
|
1.5 units on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population with available data
Submental thickness was measured using caliper devices.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=111 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=112 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 4 treatments
|
Placebo
n=102 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 4 treatments.
|
|---|---|---|---|
|
Change From Baseline in Submental Fat Thickness
|
-3.6 mm
Standard Deviation 3.67
|
-3.8 mm
Standard Deviation 4.41
|
-2.5 mm
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population with available data
The PR-SMFRS is based on the participant's response to the question "How much fat do you currently have under your chin?" 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. Improvement is defined as any decrease in score and worsened as any increase in score.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=111 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=110 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 4 treatments
|
Placebo
n=102 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 4 treatments.
|
|---|---|---|---|
|
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
Improved
|
64.9 percentage of participants
|
67.3 percentage of participants
|
44.1 percentage of participants
|
|
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
No change
|
31.5 percentage of participants
|
30.9 percentage of participants
|
48.0 percentage of participants
|
|
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
Worsened
|
3.6 percentage of participants
|
1.8 percentage of participants
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Population: Intent-to-treat population with available data
Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?" Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=111 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=110 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 4 treatments
|
Placebo
n=103 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 4 treatments.
|
|---|---|---|---|
|
Change From Baseline in Self-rating of Attractiveness
Overall Appearance
|
0.6 units on a scale
Standard Deviation 1.37
|
0.6 units on a scale
Standard Deviation 1.29
|
0.3 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Self-rating of Attractiveness
Chin / Neck
|
1.9 units on a scale
Standard Deviation 2.36
|
2.1 units on a scale
Standard Deviation 2.00
|
0.9 units on a scale
Standard Deviation 1.93
|
|
Change From Baseline in Self-rating of Attractiveness
Eyes
|
0.3 units on a scale
Standard Deviation 1.18
|
0.3 units on a scale
Standard Deviation 1.55
|
0.3 units on a scale
Standard Deviation 1.65
|
|
Change From Baseline in Self-rating of Attractiveness
Nose
|
0.4 units on a scale
Standard Deviation 1.53
|
0.4 units on a scale
Standard Deviation 1.41
|
0.5 units on a scale
Standard Deviation 1.63
|
|
Change From Baseline in Self-rating of Attractiveness
Mouth
|
0.1 units on a scale
Standard Deviation 1.02
|
0.3 units on a scale
Standard Deviation 1.25
|
0.1 units on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Self-rating of Attractiveness
Entire Face
|
0.4 units on a scale
Standard Deviation 1.21
|
0.6 units on a scale
Standard Deviation 1.12
|
0.4 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)Outcome measures
Outcome data not reported
Adverse Events
Deoxycholic Acid Injection 1 mg/cm²
Serious events: 1 serious events
Other events: 116 other events
Deaths: 0 deaths
Deoxycholic Acid Injection 2 mg/cm²
Serious events: 2 serious events
Other events: 121 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=118 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=114 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 4 treatments.
|
|---|---|---|---|
|
General disorders
Injection Site Nerve Damage
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.82%
1/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.82%
1/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.85%
1/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Nervous system disorders
Syncope
|
0.00%
0/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
Other adverse events
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=118 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 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=122 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 4 treatments
|
Placebo
n=114 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 4 treatments.
|
|---|---|---|---|
|
General disorders
Injection Site Pain
|
88.1%
104/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
87.7%
107/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
29.8%
34/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Haematoma
|
55.9%
66/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
49.2%
60/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
45.6%
52/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Anaesthesia
|
44.1%
52/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
52.5%
64/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Swelling
|
46.6%
55/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
45.1%
55/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
17.5%
20/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Erythema
|
42.4%
50/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
42.6%
52/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
21.9%
25/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Induration
|
13.6%
16/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
19.7%
24/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.88%
1/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Haemorrhage
|
12.7%
15/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
13.9%
17/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
10.5%
12/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Oedema
|
11.0%
13/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
13.9%
17/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.4%
5/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Pruritus
|
9.3%
11/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
7.4%
9/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
1.8%
2/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Paraesthesia
|
7.6%
9/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
8.2%
10/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Injection Site Hypersensitivity
|
5.9%
7/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
8.2%
10/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
1.8%
2/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Nervous system disorders
Headache
|
14.4%
17/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
6.6%
8/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
14.0%
16/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
13/118 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
6.6%
8/122 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.3%
6/114 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
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