EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
NCT ID: NCT02942160
Last Updated: 2020-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
259 participants
INTERVENTIONAL
2016-10-05
2018-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Collagenase Clostridium Histolyticum
Interventions
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Collagenase Clostridium Histolyticum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun
* Voluntarily sign and date an informed consent agreement
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun
* Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
* Be judged to be in good health
* Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal
Exclusion Criteria
* Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
* Is presently nursing a baby or providing breast milk for a baby
* Intends to become pregnant during the study
* Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
* History of stroke or bleeding
18 Years
FEMALE
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Mike McLane
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Clinical Trial Site #1
Beverly Hills, California, United States
Endo Clinical Trial Site #2
Murrieta, California, United States
Endo Clinical Trial Site #3
Oceanside, California, United States
Endo Clinical Trial Site #4
San Diego, California, United States
Endo Clinical Trial Site #5
Clearwater, Florida, United States
Endo Clinical Trial Site #6
Coral Gables, Florida, United States
Endo Clinical Trial Site #7
Palm Beach, Florida, United States
Endo Clinical Trial Site #8
Washington, Missouri, United States
Endo Clinical Trial Site #10
New York, New York, United States
Endo Clinical Trial Site #9
New York, New York, United States
Endo Clinical Trial Site #11
Nashville, Tennessee, United States
Endo Clinical Trial Site #12
Pflugerville, Texas, United States
Endo Clinical Trial Site #13
Charlottesville, Virginia, United States
Endo Clinical Trial Site #14
Lynchburg, Virginia, United States
Endo Clinical Trial Site #15
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EN3835-202
Identifier Type: -
Identifier Source: org_study_id