Trial Outcomes & Findings for Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women (NCT NCT04209530)
NCT ID: NCT04209530
Last Updated: 2021-10-07
Results Overview
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Day 71
Results posted on
2021-10-07
Participant Flow
Participant milestones
| Measure |
Buttock
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Posterolateral Thigh
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Buttock
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Posterolateral Thigh
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Overall Study
Terminated due to the major disruption in study visits and protocol assessments due to COVID-19
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
Baseline characteristics by cohort
| Measure |
Buttock
n=4 Participants
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Posterolateral Thigh
n=3 Participants
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 5.46 • n=39 Participants
|
38.3 years
STANDARD_DEVIATION 1.96 • n=41 Participants
|
43.0 years
STANDARD_DEVIATION 5.93 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
I (Pale white)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
II (Fair)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
III (Darker white)
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
IV (Light brown)
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
V (Brown)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Skin Category (Fitzpatrick Scale)
VI (Dark brown or black)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Weight
|
74.67 Kg
STANDARD_DEVIATION 12.836 • n=39 Participants
|
78.32 Kg
STANDARD_DEVIATION 1.836 • n=41 Participants
|
76.24 Kg
STANDARD_DEVIATION 9.344 • n=35 Participants
|
|
Height
|
163.83 cm
STANDARD_DEVIATION 9.390 • n=39 Participants
|
163.41 cm
STANDARD_DEVIATION 2.933 • n=41 Participants
|
163.65 cm
STANDARD_DEVIATION 6.856 • n=35 Participants
|
|
Body Mass Index
|
27.73 kg/m^2
STANDARD_DEVIATION 1.744 • n=39 Participants
|
29.50 kg/m^2
STANDARD_DEVIATION 0.300 • n=41 Participants
|
28.49 kg/m^2
STANDARD_DEVIATION 1.566 • n=35 Participants
|
PRIMARY outcome
Timeframe: Day 71Population: Because of the disruption of study conduct due to COVID-19, the study was prematurely terminated. No subjects completed assessments required for the Day 71 Visit and beyond. Only safety analyses were conducted.
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 22, Day 43 and Day 71Population: Because of the disruption of study conduct due to COVID-19, the study was prematurely terminated. No subjects completed assessments required for the Day 71 Visit and beyond. Only safety analyses were conducted.
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a clinician's perspective
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 22, Day 43 and Day 71Population: Because of the disruption of study conduct due to COVID-19, the study was prematurely terminated. No subjects completed assessments required for the Day 71 Visit and beyond. Only safety analyses were conducted.
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 71Population: Because of the disruption of study conduct due to COVID-19, the study was prematurely terminated. No subjects completed assessments required for the Day 71 Visit and beyond. Only safety analyses were conducted.
Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 71Population: Because of the disruption of study conduct due to COVID-19, the study was prematurely terminated. No subjects completed assessments required for the Day 71 Visit and beyond. Only safety analyses were conducted.
Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist
Outcome measures
Outcome data not reported
Adverse Events
Buttock
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Posterolateral Thigh
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buttock
n=4 participants at risk
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Posterolateral Thigh
n=3 participants at risk
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
General disorders
Injection site bruising
|
100.0%
4/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
100.0%
3/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site pain
|
100.0%
4/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
100.0%
3/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site discolouration
|
50.0%
2/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
0.00%
0/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site mass
|
0.00%
0/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
33.3%
1/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
General disorders
Injection site swelling
|
25.0%
1/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
0.00%
0/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
33.3%
1/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
1/4 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
0.00%
0/3 • All (Serious and Non-Serious AEs) from Day 1 to Day 265
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place