Cellulite, Edematous Fibrosclerotic Panniculopathy (EFP)
Conditions
Brief summary
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
Interventions
DRUGEN3835
Collagenase Clostridium Histolyticum (CCH)
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have both buttocks or both posterolateral thighs with: 1. A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). 2. A Hexsel Cellulite Severity Scale (CSS) Subsection A Number of Evident Depressions score of \>0, and Subsection B Depth of Depressions score of 2 )medium depth depression) or 3 (deep depressions).. 2. Have a minimum of 2 well defined and isolated cellulite dimples. 3. Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit). 4. Be judged to be in good health. 5. Have a negative pregnancy test. 6. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH. 3. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation. 4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation. 5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin. 6. Requires anticoagulant or antiplatelet medication during the study. 7. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation. 8. Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit). 9. Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening. 10. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment. 11. Has a history of keloids, hypertrophied scars, and/or other complications following biopsy. 12. Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation. 13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite. 14. Has previously received treatment with CCH in this clinical study. 15. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit. 16. Is pregnant and/or is providing breast milk or plans to become pregnant and/or to provide breast milk during the course of the study. 17. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline (Screening) in PR-PCSS | Day 71 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline (Screening) in CR-PCSS | Day 22, Day 43 and Day 71 | 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 |
| The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS) | Day 22, Day 43 and Day 71 | 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) |
| MRI Before and After CCH Treatment | Day 71 | Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment |
| Histopathology Before and After CCH Treatment | Day 71 | Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buttock EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH) | 4 |
| Posterolateral Thigh EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH) | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Posterolateral Thigh | Total | Buttock |
|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 1.96 | 43.0 years STANDARD_DEVIATION 5.93 | 46.5 years STANDARD_DEVIATION 5.46 |
| Body Mass Index | 29.50 kg/m^2 STANDARD_DEVIATION 0.3 | 28.49 kg/m^2 STANDARD_DEVIATION 1.566 | 27.73 kg/m^2 STANDARD_DEVIATION 1.744 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 163.41 cm STANDARD_DEVIATION 2.933 | 163.65 cm STANDARD_DEVIATION 6.856 | 163.83 cm STANDARD_DEVIATION 9.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) II (Fair) | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) III (Darker white) | 1 Participants | 2 Participants | 1 Participants |
| Skin Category (Fitzpatrick Scale) I (Pale white) | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) IV (Light brown) | 2 Participants | 5 Participants | 3 Participants |
| Skin Category (Fitzpatrick Scale) V (Brown) | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) VI (Dark brown or black) | 0 Participants | 0 Participants | 0 Participants |
| Weight | 78.32 Kg STANDARD_DEVIATION 1.836 | 76.24 Kg STANDARD_DEVIATION 9.344 | 74.67 Kg STANDARD_DEVIATION 12.836 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
The Change From Baseline (Screening) in PR-PCSS
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
Time frame: Day 71
Population: 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.
Secondary
Histopathology Before and After CCH Treatment
Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist
Time frame: Day 71
Population: 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.
Secondary
MRI Before and After CCH Treatment
Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment
Time frame: Day 71
Population: 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.
Secondary
The Change From Baseline (Screening) in CR-PCSS
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
Time frame: Day 22, Day 43 and Day 71
Population: 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.
Secondary
The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)
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)
Time frame: Day 22, Day 43 and Day 71
Population: 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.