Trial Outcomes & Findings for Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite (NCT NCT04677712)
NCT ID: NCT04677712
Last Updated: 2023-08-21
Results Overview
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
Day 4 (3 days after CCH-aaes injection)
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Cohort 1: CCH-aaes
Collagenase clostridium histolyticum (CCH)-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and twice daily (BID) for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only four times daily (QID) for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
9
|
9
|
8
|
7
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
7
|
8
|
9
|
9
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
9
|
9
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: CCH-aaes
Collagenase clostridium histolyticum (CCH)-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and twice daily (BID) for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only four times daily (QID) for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Baseline characteristics by cohort
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=8 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5:CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 6.32 • n=93 Participants
|
37.8 years
STANDARD_DEVIATION 9.06 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 6.85 • n=27 Participants
|
37.8 years
STANDARD_DEVIATION 7.37 • n=483 Participants
|
41.4 years
STANDARD_DEVIATION 8.01 • n=36 Participants
|
39.4 years
STANDARD_DEVIATION 5.88 • n=10 Participants
|
39.0 years
STANDARD_DEVIATION 7.08 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Body Mass Index
|
24.46 kg/m^2
STANDARD_DEVIATION 3.182 • n=93 Participants
|
26.54 kg/m^2
STANDARD_DEVIATION 2.729 • n=4 Participants
|
24.68 kg/m^2
STANDARD_DEVIATION 3.440 • n=27 Participants
|
25.50 kg/m^2
STANDARD_DEVIATION 3.094 • n=483 Participants
|
26.81 kg/m^2
STANDARD_DEVIATION 2.645 • n=36 Participants
|
24.97 kg/m^2
STANDARD_DEVIATION 2.759 • n=10 Participants
|
25.51 kg/m^2
STANDARD_DEVIATION 2.978 • n=115 Participants
|
|
Fitzpatrick Skin Rating
I (Pale White)
|
0 units on a scale
n=93 Participants
|
2 units on a scale
n=4 Participants
|
0 units on a scale
n=27 Participants
|
1 units on a scale
n=483 Participants
|
0 units on a scale
n=36 Participants
|
0 units on a scale
n=10 Participants
|
3 units on a scale
n=115 Participants
|
|
Fitzpatrick Skin Rating
II (Fair)
|
3 units on a scale
n=93 Participants
|
2 units on a scale
n=4 Participants
|
5 units on a scale
n=27 Participants
|
4 units on a scale
n=483 Participants
|
5 units on a scale
n=36 Participants
|
3 units on a scale
n=10 Participants
|
22 units on a scale
n=115 Participants
|
|
Fitzpatrick Skin Rating
III (Darker White)
|
4 units on a scale
n=93 Participants
|
4 units on a scale
n=4 Participants
|
4 units on a scale
n=27 Participants
|
4 units on a scale
n=483 Participants
|
3 units on a scale
n=36 Participants
|
4 units on a scale
n=10 Participants
|
23 units on a scale
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 4 (3 days after CCH-aaes injection)Population: Evaluable Population: All participants allocated to treatment who receive at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=8 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Left Buttock (control): None or almost no bruising (0)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Right Buttock: None or almost no bruising (0)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Left Buttock (control): mild bruising (1)
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Right Buttock: mild bruising (1)
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Left Buttock (control): Moderate bruising (2)
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Right Buttock: Moderate bruising (2)
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Left Buttock (control): severe bruising (3)
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Right Buttock: severe bruising (3)
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Left Buttock (control): very severe bruising (4)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Right Buttock: severe bruising (4)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 4 and 7Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The I-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=9 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=9 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=8 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=7 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)
Day 4
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)
Day 7
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4 and 7Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=9 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=9 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=8 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=7 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
Day 4
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
Day 7
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=8 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Left Buttock (control): Not at all bothered (1)
|
3 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Right Buttock: Not at all bothered (1)
|
3 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Left Buttock (control): A little bothered (2)
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Right Buttock: A little bothered (2)
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Left Buttock (control): Moderately bothered (3)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Right Buttock: Moderately bothered (3)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Left Buttock (control): Extremely bothered (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
Right Buttock: Extremely bothered (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 71Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=7 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
Left Buttock (control)
|
6 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
Right Buttock
|
6 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=8 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Left Buttock (control): None or almost no bruising (0)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Right Buttock: None or almost no bruising (0)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Left Buttock (control): mild bruising (1)
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Right Buttock: mild bruising (1)
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Left Buttock (control): Moderate bruising (2)
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Right Buttock: Moderate bruising (2)
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Left Buttock (control): severe bruising (3)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Right Buttock: severe bruising (3)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Left Buttock (control): very severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Right Buttock: severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=7 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=7 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Left Buttock (control): None or almost no bruising (0)
|
3 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Right Buttock: None or almost no bruising (0)
|
3 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Left Buttock (control): mild bruising (1)
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Right Buttock: mild bruising (1)
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Left Buttock (control): Moderate bruising (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Right Buttock: Moderate bruising (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Left Buttock (control): severe bruising (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Right Buttock: severe bruising (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Left Buttock (control): very severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Right Buttock: severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 22Population: Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes.
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Outcome measures
| Measure |
Cohort 1: CCH-aaes
n=6 Participants
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=7 Participants
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3: CCH-aaes + Instant Cold Packs
n=9 Participants
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 Participants
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology®
n=8 Participants
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 Participants
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Left Buttock (control): None or almost no bruising (0)
|
6 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Right Buttock: None or almost no bruising (0)
|
6 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Left Buttock (control): mild bruising (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Right Buttock: mild bruising (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Left Buttock (control): Moderate bruising (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Right Buttock: Moderate bruising (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Left Buttock (control): severe bruising (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Right Buttock: severe bruising (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Left Buttock (control): very severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Right Buttock: severe bruising (4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: CCH-aaes
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: CCH-aaes + Compression Garment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3:CCH-aaes + Instant Cold Packs
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 6: CCH-aaes + PDL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: CCH-aaes
n=7 participants at risk
CCH-aaes was administered to both buttocks without mitigation treatment (control group).
|
Cohort 2: CCH-aaes + Compression Garment
n=8 participants at risk
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
|
Cohort 3:CCH-aaes + Instant Cold Packs
n=9 participants at risk
CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment.
|
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
n=9 participants at risk
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment.
|
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
n=8 participants at risk
CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment.
|
Cohort 6: CCH-aaes + PDL
n=7 participants at risk
CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site bruising
|
85.7%
6/7 • Day 1 (after dosing) through Day 71
|
100.0%
8/8 • Day 1 (after dosing) through Day 71
|
100.0%
9/9 • Day 1 (after dosing) through Day 71
|
100.0%
9/9 • Day 1 (after dosing) through Day 71
|
100.0%
8/8 • Day 1 (after dosing) through Day 71
|
85.7%
6/7 • Day 1 (after dosing) through Day 71
|
|
General disorders
Injection site discolouration
|
28.6%
2/7 • Day 1 (after dosing) through Day 71
|
25.0%
2/8 • Day 1 (after dosing) through Day 71
|
44.4%
4/9 • Day 1 (after dosing) through Day 71
|
22.2%
2/9 • Day 1 (after dosing) through Day 71
|
25.0%
2/8 • Day 1 (after dosing) through Day 71
|
28.6%
2/7 • Day 1 (after dosing) through Day 71
|
|
General disorders
Injection site nodule
|
14.3%
1/7 • Day 1 (after dosing) through Day 71
|
25.0%
2/8 • Day 1 (after dosing) through Day 71
|
22.2%
2/9 • Day 1 (after dosing) through Day 71
|
0.00%
0/9 • Day 1 (after dosing) through Day 71
|
0.00%
0/8 • Day 1 (after dosing) through Day 71
|
42.9%
3/7 • Day 1 (after dosing) through Day 71
|
|
General disorders
Injection site pain
|
57.1%
4/7 • Day 1 (after dosing) through Day 71
|
62.5%
5/8 • Day 1 (after dosing) through Day 71
|
77.8%
7/9 • Day 1 (after dosing) through Day 71
|
77.8%
7/9 • Day 1 (after dosing) through Day 71
|
62.5%
5/8 • Day 1 (after dosing) through Day 71
|
71.4%
5/7 • Day 1 (after dosing) through Day 71
|
|
General disorders
Injection site pruritus
|
0.00%
0/7 • Day 1 (after dosing) through Day 71
|
12.5%
1/8 • Day 1 (after dosing) through Day 71
|
0.00%
0/9 • Day 1 (after dosing) through Day 71
|
0.00%
0/9 • Day 1 (after dosing) through Day 71
|
0.00%
0/8 • Day 1 (after dosing) through Day 71
|
0.00%
0/7 • Day 1 (after dosing) through Day 71
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Day 1 (after dosing) through Day 71
|
0.00%
0/8 • Day 1 (after dosing) through Day 71
|
0.00%
0/9 • Day 1 (after dosing) through Day 71
|
11.1%
1/9 • Day 1 (after dosing) through Day 71
|
12.5%
1/8 • Day 1 (after dosing) through Day 71
|
0.00%
0/7 • Day 1 (after dosing) through Day 71
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place