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History of Changes for Study: NCT02942160
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Latest version (submitted November 2, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 20, 2016 None (earliest Version on record)
2 December 19, 2016 Study Status
3 February 8, 2017 Study Status
4 April 12, 2017 Study Status
5 June 15, 2017 Study Status
6 October 16, 2017 Recruitment Status and Study Status
7 April 10, 2018 Study Status
8 July 12, 2018 Recruitment Status, Study Status, Study Design, Contacts/Locations and Arms and Interventions
9 October 9, 2018 Study Status and Contacts/Locations
10 June 12, 2019 Study Status and Contacts/Locations
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Results Submission Events
11 November 2, 2020 Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Study Design
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Study NCT02942160
Submitted Date:  October 20, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: EN3835-202
Brief Title: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Official Title: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Enrolling by invitation
Study Start: October 2016
Primary Completion: April 2017 [Anticipated]
Study Completion: May 2017 [Anticipated]
First Submitted: October 20, 2016
First Submitted that
Met QC Criteria:
October 20, 2016
First Posted: October 21, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 20, 2016
Last Update Posted: October 21, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Endo Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Detailed Description:
Open or close this module Conditions
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 350 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: EN3835 Active
EB3835 0.84mg (Collagenase Clostridium Histolyticum)
Biological: Collagenase Clostridium Histolyticum
Other Names:
  • Xiaflex
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Locations: United States, California
Clinical Testing Center of Beverly Hills
Beverly Hills, California, United States, 90210
Dermatology Specialists, Inc
Murrieta, California, United States, 92562
Dermatology Specialists, Inc.
Oceanside, California, United States, 92056
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States, 92121
United States, Florida
Olympian Clinical Research
Clearwater, Florida, United States, 33756
Skin Research Institute LLC
Coral Gables, Florida, United States, 33146
Research Institute of the Southeast
Palm Beach, Florida, United States, 33401
United States, Missouri
Mercy Health Research
Washington, Missouri, United States, 63091
United States, New York
Bass Plastic Surgery PLLC
New York, New York, United States, 10065
Sadick Dermatology
New York, New York, United States, 10075
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Pflugerville Dermatology Clinical Research Center, Inc.
Pflugerville, Texas, United States, 78660
United States, Virginia
Charlottesville Dermatology Research Center
Charlottesville, Virginia, United States, 22911
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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