Trial Outcomes & Findings for Phase 2 Study for the Treatment of Superficial Lipomas (NCT NCT00608842)
NCT ID: NCT00608842
Last Updated: 2016-01-14
Results Overview
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2016-01-14
Participant Flow
Participant milestones
| Measure |
Deoxycholic Acid 1%
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
17
|
|
Overall Study
COMPLETED
|
14
|
14
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Deoxycholic Acid 1%
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Overall Study
Participant's Request
|
0
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2 Study for the Treatment of Superficial Lipomas
Baseline characteristics by cohort
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=14 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
47.2 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety population (all participants who received at least 1 dose of study medication)
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
12 participants
|
13 participants
|
14 participants
|
12 participants
|
|
Number of Participants With Adverse Events (AEs)
Any treatment-related adverse event
|
6 participants
|
9 participants
|
8 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
Any serious adverse event
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any severe adverse event
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any adverse event leading to drug discontinuation
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety population
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Blood triglycerides
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Alanine transaminase
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Aspartate aminotransferase
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Alkaline phosphatase
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Urinalysis - Glucose
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety population
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening (prior to randomization)Population: Safety population with biopsy results at screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=13 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=12 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=13 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=14 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Positive Histopathology Results at Screening
Chronic inflammation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Positive Histopathology Results at Screening
Acute inflammation
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Positive Histopathology Results at Screening
Fibrosis/scarring
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Positive Histopathology Results at Screening
Hemorrhage
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Positive Histopathology Results at Screening
Mature adipose tissue
|
11 participants
|
11 participants
|
13 participants
|
13 participants
|
|
Number of Participants With Positive Histopathology Results at Screening
Necrosis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Week 20Population: Safety population with biopsy results at week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=13 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=16 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Number of Participants With Positive Histopathology Results at Week 20
Necrosis
|
14 participants
|
13 participants
|
14 participants
|
3 participants
|
|
Number of Participants With Positive Histopathology Results at Week 20
Acute inflammation
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Positive Histopathology Results at Week 20
Chronic inflammation
|
10 participants
|
12 participants
|
13 participants
|
0 participants
|
|
Number of Participants With Positive Histopathology Results at Week 20
Fibrosis/scarring
|
13 participants
|
12 participants
|
14 participants
|
6 participants
|
|
Number of Participants With Positive Histopathology Results at Week 20
Hemorrhage
|
5 participants
|
5 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Positive Histopathology Results at Week 20
Mature adipose tissue
|
15 participants
|
13 participants
|
15 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline and week 20 (8 weeks after last dose)Population: MITT Population
At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=14 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
Complete Clearance
|
0.0 percentage of participants
|
0.0 percentage of participants
|
7.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
≥ 75% Cleared
|
13.3 percentage of participants
|
6.7 percentage of participants
|
14.3 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)Population: MITT Population
Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size.
Outcome measures
| Measure |
Deoxycholic Acid 1%
n=15 Participants
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 Participants
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=14 Participants
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 Participants
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Week 12
|
41.2 percent change
Standard Deviation 31.5
|
28.5 percent change
Standard Deviation 46.0
|
18.0 percent change
Standard Deviation 34.9
|
38.5 percent change
Standard Deviation 32.4
|
|
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Week 16
|
43.9 percent change
Standard Deviation 30.1
|
23.3 percent change
Standard Deviation 41.8
|
20.0 percent change
Standard Deviation 38.2
|
32.1 percent change
Standard Deviation 40.5
|
|
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Week 20
|
50.1 percent change
Standard Deviation 30.6
|
25.9 percent change
Standard Deviation 42.6
|
35.9 percent change
Standard Deviation 40.7
|
36.7 percent change
Standard Deviation 38.0
|
Adverse Events
Deoxycholic Acid 1%
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Deoxycholic Acid 2%
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Deoxycholic Acid 4%
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deoxycholic Acid 1%
n=15 participants at risk
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 participants at risk
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 participants at risk
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 participants at risk
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Patella Fracture
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Tibia Fracture
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
Other adverse events
| Measure |
Deoxycholic Acid 1%
n=15 participants at risk
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 2%
n=15 participants at risk
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Deoxycholic Acid 4%
n=15 participants at risk
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
Placebo
n=17 participants at risk
Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
|
|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
40.0%
6/15 • 24 weeks
|
40.0%
6/15 • 24 weeks
|
26.7%
4/15 • 24 weeks
|
17.6%
3/17 • 24 weeks
|
|
General disorders
Injection Site Bruising
|
20.0%
3/15 • 24 weeks
|
26.7%
4/15 • 24 weeks
|
40.0%
6/15 • 24 weeks
|
29.4%
5/17 • 24 weeks
|
|
General disorders
Injection Site Pain
|
20.0%
3/15 • 24 weeks
|
26.7%
4/15 • 24 weeks
|
33.3%
5/15 • 24 weeks
|
17.6%
3/17 • 24 weeks
|
|
General disorders
Injection Site Induration
|
13.3%
2/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
17.6%
3/17 • 24 weeks
|
|
General disorders
Injection Site Anaesthesia
|
13.3%
2/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
13.3%
2/15 • 24 weeks
|
17.6%
3/17 • 24 weeks
|
|
General disorders
Injection Site Discolouration
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
General disorders
Injection Site Pruritus
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Swelling
|
13.3%
2/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
General disorders
Injection Site Irritation
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
13.3%
2/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
General disorders
Injection Site Ulcer
|
13.3%
2/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
13.3%
2/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Discharge
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Haemorrhage
|
13.3%
2/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
General disorders
Injection Site Desquamation
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Inflammation
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Rash
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
General disorders
Injection Site Warmth
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
20.0%
3/15 • 24 weeks
|
11.8%
2/17 • 24 weeks
|
|
Infections and infestations
Influenza
|
20.0%
3/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
11.8%
2/17 • 24 weeks
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
11.8%
2/17 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Infections and infestations
Vaginitis Bacterial
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
11.8%
2/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • 24 weeks
|
13.3%
2/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Jaundice
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Investigations
Urine Colour Abnormal
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
5.9%
1/17 • 24 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
|
Hepatobiliary disorders
Hepatitis C
|
0.00%
0/15 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
6.7%
1/15 • 24 weeks
|
0.00%
0/17 • 24 weeks
|
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 Biopharmaceuticals, Inc. prior to presenting and/or publishing results of this study.
- Publication restrictions are in place
Restriction type: OTHER