EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
- Conditions
- Edematous Fibrosclerotic PanniculopathyCellulite
- Interventions
- Biological: Placebo ComparatorBiological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
- Registration Number
- NCT02724644
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 375
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Be a female ≥18 years of age
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At Screening visit, have at least 1 quadrant with:
- a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and
- a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
- a Hexsel CSS score no greater than 13
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At Day 1 visit, have an assigned quadrant with:
- a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
- a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
- a Hexsel CSS score no greater than 13
-
Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study).
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Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
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Have a negative urine pregnancy test at screening and be using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator; or post-menopausal for at least 1 year; or be surgically sterile.
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Be willing and able to cooperate with the requirements of the study
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Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
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Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English
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Has any of the following conditions:
- Thyroid disease, unless controlled with medication for ≥6 months
- Uncontrolled diabetes mellitus, as determined by the Investigator
- Uncontrolled hypertension, as determined by the Investigator
- Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
- Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent)
- History of lower extremity thrombosis or post-thrombosis syndrome
- Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
- Inflammation or active infection in area to be treated
- Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer
- History of keloidal scarring or abnormal wound healing
- Coagulation disorder
- Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EN3835 Placebo Placebo Comparator Placebo EN3835 Active COLLAGENASE CLOSTRIDIUM HISTOLYTICUM EN3835 0.84 mg (Collagenase Clostridium Histolyticum). Each subject can receive up to three treatment sessions. Each treatment session will be separated by approximately 21 days.
- Primary Outcome Measures
Name Time Method Percentage of Composite Responders of at Least 2-Level Improvement of Severity Baseline, Day 71 Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.
- Secondary Outcome Measures
Name Time Method Percentage of Composite Responders of at Least 1-Level Improvement of Severity Baseline, Day 71 Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.
CR-PCSS Responder Analysis: 2-Levels of Severity Baseline, Day 71 Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
CR-PCSS Responder Analysis: 1-Level of Severity Baseline, Day 71 Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
CR-PCSS Change From Baseline Baseline, Day 71 The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
PR-PCSS Responder Analysis: 2-Levels of Severity Baseline, Day 71 Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
PR-PCSS Responder Analysis: 1-Level of Severity Baseline, Day 71 Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
PR-PCSS Change From Baseline Baseline, Day 71 The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) Day 71 On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) Day 71 At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale Day 71 At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score Baseline, Day 71 Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity
Trial Locations
- Locations (15)
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Skin Research Institute LLC
🇺🇸Coral Gables, Florida, United States
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
🇺🇸San Diego, California, United States
Olympian Clinical Research
🇺🇸Clearwater, Florida, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Bass Plastic Surgery, PLLC
🇺🇸New York, New York, United States
Sadick Research Group
🇺🇸New York, New York, United States
Mercy Health Research
🇺🇸Washington, Missouri, United States
Clinical Testing of Beverly Hills
🇺🇸Beverly Hills, California, United States
The Education & Research Foundation
🇺🇸Lynchburg, Virginia, United States
Dermatology Specialists, Inc
🇺🇸Oceanside, California, United States
Research Institute of the Southeast
🇺🇸West Palm Beach, Florida, United States
Charlottesville Medical Research Center LLC
🇺🇸Charlottesville, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States