Trial Outcomes & Findings for A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma (NCT NCT01613313)
NCT ID: NCT01613313
Last Updated: 2016-10-06
Results Overview
The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline and Six months post injection of study drug
Results posted on
2016-10-06
Participant Flow
Subjects were screened and enrolled at 1 site in the United States
Participant milestones
| Measure |
Dose #1
single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #2
single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #3
single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #4
single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Baseline characteristics by cohort
| Measure |
Dose #1
n=2 Participants
single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #2
n=4 Participants
single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #3
n=4 Participants
single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #4
n=4 Participants
single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.0 Years
STANDARD_DEVIATION 5.66 • n=99 Participants
|
51.5 Years
STANDARD_DEVIATION 12.50 • n=107 Participants
|
41.3 Years
STANDARD_DEVIATION 11.09 • n=206 Participants
|
57.0 Years
STANDARD_DEVIATION 4.97 • n=7 Participants
|
49.6 Years
STANDARD_DEVIATION 10.60 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
14 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Six months post injection of study drugPopulation: Analysis population consists of all subjects who were enrolled and received the administration of study drug.
The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.
Outcome measures
| Measure |
Dose #1
n=2 Participants
single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #2
n=4 Participants
single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #3
n=4 Participants
single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #4
n=4 Participants
single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
|---|---|---|---|---|
|
Change in Visible Surface Area of the Lipoma
|
-31.69 Percent change from baseline
Standard Deviation 80.83
|
-47.57 Percent change from baseline
Standard Deviation 23.48
|
-52.42 Percent change from baseline
Standard Deviation 50.61
|
-66.60 Percent change from baseline
Standard Deviation 17.82
|
SECONDARY outcome
Timeframe: Baseline and 6 months post injection of study drugPopulation: Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug
A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.
Outcome measures
| Measure |
Dose #1
n=2 Participants
single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #2
n=4 Participants
single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #3
n=4 Participants
single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #4
n=3 Participants
single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
|---|---|---|---|---|
|
Relative Change in Volume of the Lipoma
|
-54.16 Percent reduction from baseline
Standard Deviation 34.3
|
-62.33 Percent reduction from baseline
Standard Deviation 30.39
|
-11.35 Percent reduction from baseline
Standard Deviation 32.12
|
-34.75 Percent reduction from baseline
Standard Deviation 24.21
|
Adverse Events
Dose #1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose #2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose #3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose #4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose #1
n=2 participants at risk
single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #2
n=4 participants at risk
single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #3
n=4 participants at risk
single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
Dose #4
n=4 participants at risk
single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
|
|---|---|---|---|---|
|
General disorders
Bruising
|
50.0%
1/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
75.0%
3/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
75.0%
3/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
100.0%
4/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
75.0%
3/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
75.0%
3/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
General disorders
Swelling
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
75.0%
3/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Vascular disorders
Contusion
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Cardiac disorders
Dizziness
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/2 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
25.0%
1/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
0.00%
0/4 • Adverse Events were collected from Day 0 through 6 months post administration of study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER