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EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942160
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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Brief Summary:
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy Cellulite Biological: Collagenase Clostridium Histolyticum Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Actual Study Start Date : October 5, 2016
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
 Biological: Collagenase Clostridium Histolyticum
Other Name: Xiaflex


Outcome Measures
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Primary Outcome Measures :
  1. Primary cellulite severity endpoint defined as proportion of composite responders at day 71 [ Time Frame: Day 71 ]

Secondary Outcome Measures :
  1. Proportion of composite responders defined as subjects with an improvement in severity in the CR-PCSS (Clinician-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  2. Proportion of composite responders defined as subjects with an improvement in severity in the PR-PCSS (Patient-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  3. Proportion of responders at each level of improvement in the PR-PCSS (Patient-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  4. Proportion of responders at each level of improvement in the CR-PCSS (Clinician-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  5. Proportion of responders with a response of 1 or better in the I-GAIS (Investigator-Global Aesthetic Improvement Scale) [ Time Frame: Day 71 ]
  6. Proportion of responders with a response of 1 or better in the S-GAIS (Subject-Global Aesthetic Improvement Scale) [ Time Frame: Day 71 ]
  7. Proportion of responders at each level of the subject satisfaction with cellulite treatment [ Time Frame: Day 71 ]
  8. Change in the Hexsel CSS total score [ Time Frame: Day 1 to Day 71 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Observation Phase:

  • 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

Inclusion Criteria for Treatment Phase:

  • 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 for Observation Phase:

  • None

Exclusion Criteria for Treatment Phase:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942160


Locations
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United States, California
Endo Clinical Trial Site #1
Beverly Hills, California, United States, 90210
Endo Clinical Trial Site #2
Murrieta, California, United States, 92562
Endo Clinical Trial Site #3
Oceanside, California, United States, 92056
Endo Clinical Trial Site #4
San Diego, California, United States, 92121
United States, Florida
Endo Clinical Trial Site #5
Clearwater, Florida, United States, 33756
Endo Clinical Trial Site #6
Coral Gables, Florida, United States, 33146
Endo Clinical Trial Site #7
Palm Beach, Florida, United States, 33401
United States, Missouri
Endo Clinical Trial Site #8
Washington, Missouri, United States, 63091
United States, New York
Endo Clinical Trial Site #10
New York, New York, United States, 10065
Endo Clinical Trial Site #9
New York, New York, United States, 10075
United States, Tennessee
Endo Clinical Trial Site #11
Nashville, Tennessee, United States, 37215
United States, Texas
Endo Clinical Trial Site #12
Pflugerville, Texas, United States, 78660
United States, Virginia
Endo Clinical Trial Site #13
Charlottesville, Virginia, United States, 22911
Endo Clinical Trial Site #14
Lynchburg, Virginia, United States, 24501
United States, Washington
Endo Clinical Trial Site #15
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Mike McLane Endo Pharmaceuticals
More Information
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02942160    
Other Study ID Numbers: EN3835-202
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Cellulite
Edema
Skin Manifestations
Signs and Symptoms