EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
NCT ID: NCT02724644
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
375 participants
INTERVENTIONAL
2016-02-29
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EN3835 Active
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.
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Injectable intervention
EN3835 Placebo
Placebo
Placebo Comparator
Interventions
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COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Injectable intervention
Placebo Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
* Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
* 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.
* Be willing and able to cooperate with the requirements of the study
* Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
* Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Clinical Testing of Beverly Hills
Beverly Hills, California, United States
Dermatology Specialists, Inc
Murrieta, California, United States
Dermatology Specialists, Inc
Oceanside, California, United States
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
San Diego, California, United States
Olympian Clinical Research
Clearwater, Florida, United States
Skin Research Institute LLC
Coral Gables, Florida, United States
Research Institute of the Southeast
West Palm Beach, Florida, United States
Mercy Health Research
Washington, Missouri, United States
Bass Plastic Surgery, PLLC
New York, New York, United States
Sadick Research Group
New York, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, United States
The Education & Research Foundation
Lynchburg, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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EN3835-201
Identifier Type: -
Identifier Source: org_study_id