Trial Outcomes & Findings for Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat (NCT NCT00618722)
NCT ID: NCT00618722
Last Updated: 2015-07-14
Results Overview
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Results posted on
2015-07-14
Participant Flow
The study was conducted at 6 study centers: 1 in the United Kingdom, 2 in Canada, and 3 in Australia.
Enrollment was conducted in 2 stages, an initial cohort in which preliminary safety and tolerability were evaluated and a second cohort (contingent cohort), which was enrolled after it had been determined that acceptable safety and tolerability were observed in the initial cohort. Participants from both cohorts were pooled for analysis.
Participant milestones
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) 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 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) 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 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
22
|
|
Overall Study
Received Treatment
|
20
|
20
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
18
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) 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 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) 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 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Overall Study
Refusal of Treatment
|
0
|
0
|
1
|
0
|
|
Overall Study
Patient Request
|
1
|
1
|
1
|
1
|
|
Overall Study
Inability to Complete Study Procedure
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
2
|
|
Overall Study
Miscellaneous Reasons
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Baseline characteristics by cohort
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.71 • n=99 Participants
|
45.5 years
STANDARD_DEVIATION 7.37 • n=107 Participants
|
44.4 years
STANDARD_DEVIATION 6.95 • n=206 Participants
|
48.0 years
STANDARD_DEVIATION 9.78 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 8.55 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
22 participants
n=206 Participants
|
21 participants
n=7 Participants
|
82 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Weight
|
77.56 kg
STANDARD_DEVIATION 14.022 • n=99 Participants
|
68.53 kg
STANDARD_DEVIATION 12.472 • n=107 Participants
|
79.28 kg
STANDARD_DEVIATION 12.950 • n=206 Participants
|
80.13 kg
STANDARD_DEVIATION 11.083 • n=7 Participants
|
76.53 kg
STANDARD_DEVIATION 13.239 • n=31 Participants
|
|
Submental Fat (SMF) Rating
2
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
13 participants
n=206 Participants
|
13 participants
n=7 Participants
|
51 participants
n=31 Participants
|
|
Submental Fat (SMF) Rating
3
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
9 participants
n=206 Participants
|
9 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Fitzpatrick Skin Type
I-III
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
22 participants
n=206 Participants
|
22 participants
n=7 Participants
|
84 participants
n=31 Participants
|
|
Fitzpatrick Skin Type
IV-VI
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).Population: Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation.
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Adverse event associated with treatment area
|
20 participants
|
19 participants
|
21 participants
|
20 participants
|
|
Number of Participants With Adverse Events
Any adverse event
|
20 participants
|
19 participants
|
22 participants
|
21 participants
|
|
Number of Participants With Adverse Events
Study drug-related adverse event
|
20 participants
|
19 participants
|
21 participants
|
20 participants
|
|
Number of Participants With Adverse Events
Severe adverse event
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Study drug-related severe adverse event
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Serious adverse event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Discontinued due to adverse event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).Population: Safety/mITT population
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Laboratory Values
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Weight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Physical Examinations
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)Population: Safety/mITT population with available data
The SMF rating scale 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=17 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=19 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=19 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=20 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Change From Baseline in Submental Fat (SMF) Rating Scale Score
|
-0.9 units on a scale
Standard Deviation 0.70
|
-0.8 units on a scale
Standard Deviation 0.60
|
-0.7 units on a scale
Standard Deviation 0.75
|
-0.5 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)Population: Safety/mITT population with available data
The Subject Satisfaction with Appearance Rating Scale assesses participants' 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=17 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=18 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=18 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=20 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
|
3.8 units on a scale
Standard Deviation 1.85
|
3.3 units on a scale
Standard Deviation 1.78
|
3.5 units on a scale
Standard Deviation 1.42
|
1.9 units on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: 4 weeks after last treatment (up to 16 weeks after first dose)Population: Safety/mITT population
Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Percentage of Participants With a Response in the Subject Global Improvement Rating
|
88.9 percentage of participants
|
78.9 percentage of participants
|
94.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)Population: Safety/mITT population with available data
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Change From Baseline in Skin Laxity Rating
Week 4
|
0.1 units on a scale
Interval -0.1 to 0.3
|
-0.1 units on a scale
Interval -0.4 to 0.1
|
0.0 units on a scale
Interval -0.2 to 0.3
|
-0.2 units on a scale
Interval -0.4 to 0.0
|
|
Change From Baseline in Skin Laxity Rating
Week 8
|
0.1 units on a scale
Interval -0.1 to 0.4
|
-0.1 units on a scale
Interval -0.4 to 0.1
|
0.1 units on a scale
Interval -0.1 to 0.3
|
-0.1 units on a scale
Interval -0.4 to 0.1
|
|
Change From Baseline in Skin Laxity Rating
Week 12
|
0.1 units on a scale
Interval -0.1 to 0.3
|
0.1 units on a scale
Interval -0.2 to 0.3
|
0.0 units on a scale
Interval -0.2 to 0.2
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
|
Change From Baseline in Skin Laxity Rating
Week 16
|
0.1 units on a scale
Interval -0.2 to 0.3
|
-0.2 units on a scale
Interval -0.4 to 0.0
|
0.0 units on a scale
Interval -0.2 to 0.2
|
0.0 units on a scale
Interval -0.3 to 0.2
|
|
Change From Baseline in Skin Laxity Rating
Week 24
|
0.1 units on a scale
Interval -0.2 to 0.3
|
-0.3 units on a scale
Interval -0.5 to 0.0
|
0.0 units on a scale
Interval -0.2 to 0.2
|
-0.1 units on a scale
Interval -0.4 to 0.1
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)Population: Safety/mITT population with available data
The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.
Outcome measures
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=7 Participants
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=11 Participants
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=8 Participants
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=13 Participants
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Change From Baseline in the Cervicomental Angle
|
-0.7 degrees
Standard Deviation 3.45
|
2.3 degrees
Standard Deviation 13.67
|
6.9 degrees
Standard Deviation 10.67
|
-2.3 degrees
Standard Deviation 9.71
|
Adverse Events
Deoxycholic Acid Injection 1 mg/cm²
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Deoxycholic Acid Injection 2 mg/cm²
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Deoxycholic Acid Injection 4 mg/cm²
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deoxycholic Acid Injection 1 mg/cm²
n=20 participants at risk
Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 2 mg/cm²
n=20 participants at risk
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Deoxycholic Acid Injection 4 mg/cm²
n=22 participants at risk
Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
Placebo
n=22 participants at risk
Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
95.0%
19/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
80.0%
16/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
86.4%
19/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
77.3%
17/22 • 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
|
85.0%
17/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
85.0%
17/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
86.4%
19/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
45.5%
10/22 • 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
|
75.0%
15/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
75.0%
15/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
81.8%
18/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
54.5%
12/22 • 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
|
85.0%
17/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
65.0%
13/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
77.3%
17/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
18.2%
4/22 • 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
|
40.0%
8/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
30.0%
6/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
45.5%
10/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • 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 Nodule
|
30.0%
6/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
30.0%
6/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
31.8%
7/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
15.0%
3/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
25.0%
5/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
27.3%
6/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • 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
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
13.6%
3/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
10.0%
2/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • 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 Discomfort
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
General disorders
Influenza Like Illness
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Tonsillitis
|
10.0%
2/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
2/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
15.0%
3/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
18.2%
4/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
13.6%
3/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
4.5%
1/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
9.1%
2/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
Musculoskeletal Pain
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
Pain In Extremity
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
Plantar Fasciitis
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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
Neck Pain
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
13.6%
3/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
5.0%
1/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/20 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
|
0.00%
0/22 • 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