Trial Outcomes & Findings for A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (NCT NCT01987986)
NCT ID: NCT01987986
Last Updated: 2017-10-05
Results Overview
Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Baseline, Day 73
Results posted on
2017-10-05
Participant Flow
Participant milestones
| Measure |
AA4500 0.06 mg (Low Dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
40
|
24
|
|
Overall Study
COMPLETED
|
41
|
43
|
38
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
AA4500 0.06 mg (Low Dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
0
|
Baseline Characteristics
A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy
Baseline characteristics by cohort
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 5.78 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 5.62 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 8.08 • n=4 Participants
|
36.9 years
STANDARD_DEVIATION 6.50 • n=21 Participants
|
|
Age, Customized
<25
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Customized
25-34
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Age, Customized
35-44
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Age, Customized
>=45
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
40 participants
n=5 Participants
|
24 participants
n=4 Participants
|
150 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 73Population: All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.
Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Investigator Global Assessment of Aesthetic Improvement
|
0.7 units on a scale
Standard Deviation 0.82
|
0.9 units on a scale
Standard Deviation 0.93
|
1.1 units on a scale
Standard Deviation 0.91
|
0.5 units on a scale
Standard Deviation 0.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 73Population: All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.
The CSS is a photonumeric scale that was used to evaluate 5 morphologic features of cellulite; (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature including Nuernberger and Mueller. The severity of each feature is rated on a scale from 0 (none) to 3 (most severe). The CSS total score is the sum of the 5 cellulite features (range: 0 to 15, with higher scores corresponding to more severe cellulite). Change is Day 73 study visit rating minus baseline rating; negative values indicate improvement in cellulite.
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Investigator Cellulite Severity Score (CSS) Total Score- Change From Baseline
|
-1.1 units on a scale
Standard Deviation 1.74
|
-1.3 units on a scale
Standard Deviation 1.70
|
-1.9 units on a scale
Standard Deviation 2.37
|
-0.7 units on a scale
Standard Deviation 1.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 73Population: All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.
CSI scores ranged from 0 (no cellulite present), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). Change is Day 73 study visit rating minus baseline rating; negative values indicate a lessening in cellulite severity.
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject Cellulite Severity Item (CSI)-Change From Baseline
|
-0.7 units on a scale
Standard Deviation 1.22
|
-1.1 units on a scale
Standard Deviation 1.07
|
-1.3 units on a scale
Standard Deviation 1.34
|
-0.8 units on a scale
Standard Deviation 1.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 73Population: All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.
Subjects rated their cellulite on a scale from 0 (not at all bothered) to 4 (extremely bothered). Change from baseline is Day 73 study visit value minus baseline value; negative change reflects an improvement in the amount the subject was bothered by cellulite; positive change reflects a worsening in the amount the subject is bothered by cellulite.
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject Global Bother Assessment (SGBA)- Change From Baseline
|
-0.9 units on a scale
Standard Deviation 1.33
|
-1.0 units on a scale
Standard Deviation 1.23
|
-1.0 units on a scale
Standard Deviation 1.12
|
-1.0 units on a scale
Standard Deviation 1.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 73Population: All subjects who received at least one injection and who had at least one post-injection efficacy measurement.
Subjects were asked to answer 6 exploratory questions regarding the appearance of their cellulite on a scale of 0 to 10 with 0 representing "not at all" and 10 representing "extremely." A SR-CIS total score was derived from these 6 questions with values varying from 0 (No negative impact) to 60 (Extreme negative impact). Change from baseline is Day 73 value minus baseline value; negative change reflects an improvement.
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject-reported Cellulite Impact Scale (SR-CIS)-Change From Baseline
|
-15.0 units on a scale
Standard Deviation 18.9
|
-18.0 units on a scale
Standard Deviation 15.70
|
-17.7 units on a scale
Standard Deviation 14.61
|
-11.9 units on a scale
Standard Deviation 13.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 73Population: All subjects who received at least one injection of study drug and had at least one post -injection efficacy measurement.
Subjects rated their treatment satisfaction at the Day 73 visit on a 5-point scale ranging from -2 (very dissatisfied) to +2 (very satisfied)
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject Satisfaction With Treatment Assessment (SCTA)
|
0.0 units on a scale
Standard Deviation 1.31
|
0.9 units on a scale
Standard Deviation 0.89
|
0.7 units on a scale
Standard Deviation 0.93
|
0.1 units on a scale
Standard Deviation 1.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 73Population: All subjects who at least one injection of study drug and had at least one post-injection efficacy measurement.
Subjects assessed their cellulite based on a 5-point scale from -1 (slightly worse), 0 (same), 1 (slightly improved), 2 (moderately improved), to 3 (much improved) on Day 73
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject Global Assessment Cellulite (SGA-C)
|
0.9 units on a scale
Standard Deviation 1.23
|
1.6 units on a scale
Standard Deviation 0.85
|
1.5 units on a scale
Standard Deviation 1.04
|
0.8 units on a scale
Standard Deviation 0.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 73Population: All subjects who received at least one injection of study medication and had at least one post injection efficacy measurement.
Subjects's assessment of aesthetic improvement (C-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).
Outcome measures
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 Participants
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 Participants
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Subject Global Assessment of Aesthetic Improvement (C-GAIS)
|
0.9 units on a scale
Standard Deviation 1.14
|
1.6 units on a scale
Standard Deviation 0.88
|
1.4 units on a scale
Standard Deviation 1.03
|
0.7 units on a scale
Standard Deviation 0.91
|
Adverse Events
AA4500 0.06 mg (Low Dose)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
AA4500 0.48 mg (Mid-dose)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
AA4500 0.84 mg (High Dose)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 participants at risk
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
Infections and infestations
Pharyngeal absess
|
2.3%
1/43
|
0.00%
0/43
|
0.00%
0/40
|
0.00%
0/24
|
Other adverse events
| Measure |
AA4500 0.06 mg (Low Dose)
n=43 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.48 mg (Mid-dose)
n=43 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
AA4500 0.84 mg (High Dose)
n=40 participants at risk
AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention
|
Placebo
n=24 participants at risk
Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo
|
|---|---|---|---|---|
|
General disorders
Injection site brusing
|
62.8%
27/43 • Number of events 51
|
69.8%
30/43 • Number of events 60
|
70.0%
28/40 • Number of events 58
|
25.0%
6/24 • Number of events 7
|
|
General disorders
Injection site pain
|
25.6%
11/43 • Number of events 15
|
41.9%
18/43 • Number of events 38
|
52.5%
21/40 • Number of events 41
|
8.3%
2/24 • Number of events 4
|
|
General disorders
Injection site pruritus
|
0.00%
0/43
|
11.6%
5/43 • Number of events 8
|
17.5%
7/40 • Number of events 10
|
0.00%
0/24
|
|
General disorders
Injection site swelling
|
7.0%
3/43 • Number of events 3
|
16.3%
7/43 • Number of events 14
|
12.5%
5/40 • Number of events 8
|
0.00%
0/24
|
|
General disorders
Injection site discoloration
|
0.00%
0/43
|
11.6%
5/43 • Number of events 6
|
15.0%
6/40 • Number of events 6
|
0.00%
0/24
|
|
General disorders
Injection site induration
|
0.00%
0/43
|
0.00%
0/43
|
7.5%
3/40 • Number of events 3
|
0.00%
0/24
|
|
General disorders
Injection site discomfort
|
0.00%
0/43
|
0.00%
0/43
|
5.0%
2/40 • Number of events 3
|
0.00%
0/24
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/43
|
0.00%
0/43
|
5.0%
2/40 • Number of events 3
|
0.00%
0/24
|
|
General disorders
Injection site nodule
|
0.00%
0/43
|
0.00%
0/43
|
5.0%
2/40 • Number of events 2
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER