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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

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE October 5, 2016
Actual Primary Completion Date June 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
Primary cellulite severity endpoint defined as proportion of composite responders at day 71 [ Time Frame: Day 71 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
  • 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 ]
  • 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 ]
  • Proportion of responders at each level of improvement in the PR-PCSS (Patient-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  • Proportion of responders at each level of improvement in the CR-PCSS (Clinician-Reported Photonumeric Cellulite Severity Scale) [ Time Frame: Day 71 ]
  • Proportion of responders with a response of 1 or better in the I-GAIS (Investigator-Global Aesthetic Improvement Scale) [ Time Frame: Day 71 ]
  • Proportion of responders with a response of 1 or better in the S-GAIS (Subject-Global Aesthetic Improvement Scale) [ Time Frame: Day 71 ]
  • Proportion of responders at each level of the subject satisfaction with cellulite treatment [ Time Frame: Day 71 ]
  • Change in the Hexsel CSS total score [ Time Frame: Day 1 to Day 71 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Official Title  ICMJE A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Brief Summary A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Edematous Fibrosclerotic Panniculopathy
  • Cellulite
Intervention  ICMJE Biological: Collagenase Clostridium Histolyticum
Other Name: Xiaflex
Study Arms  ICMJE Experimental: EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Intervention: Biological: Collagenase Clostridium Histolyticum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2016)
350
Actual Study Completion Date  ICMJE June 14, 2018
Actual Primary Completion Date June 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02942160
Other Study ID Numbers  ICMJE EN3835-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike McLane Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP