Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy

This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.

Study Overview

• Status: Completed
• Conditions: Edematous Fibrosclerotic Panniculopathy
• Intervention / Treatment: Biological: Previously Treated with EN3835

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • Endo Clinical Trial Site #4
    • Coral Gables, Florida, United States, 33146
      • Endo Clinical Trial Site #1
  • Missouri
    • Washington, Missouri, United States, 63090
      • Endo Clinical Trial Site #5
  • New York
    • New York, New York, United States, 10065
      • Endo Clinical Trial Site #2
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Endo Clinical Trial Site #3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Up to 8 subjects who completed the EN3835-201 and EN3835-202 studies and who had a composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in the EN3835-201 study.

Description

Inclusion Criteria:

• To qualify for the study a subject must:

  1. Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  2. Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
  3. Be willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

• Subjects will be ineligible for participation in this study if the subject:

  1. Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202.
  2. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.

  3. Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.

     1. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
     2. Any investigational treatment for EFP/cellulite.
     3. Endermologie® or similar treatments.
     4. Massage therapy.
     5. Creams (eg, Celluvera™, TriLastin®).
  4. Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Treatment; Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in the EN3835-201 study, will be eligible for this study. The study will consist of up to two evaluations approximately 3 years after the first dose of study drug was received in the EN3835-201 study.	Biological: Previously Treated with EN3835; No treatment to be administered - Observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)	Change from baseline (pre-dose, Day 1) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)	Change from baseline (pre-dose, Day 1) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)	Change from reference time point (Day 71) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)	Change from reference time point (Day 71) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2019
• Primary Completion (ACTUAL): June 25, 2019
• Study Completion (ACTUAL): June 25, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: EFP; Cellulite; Edematous Fibrosclerotic Panniculopathy
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: EN3835-219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No