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

Completed

• Conditions: Edematous Fibrosclerotic Panniculopathy

• Registration Number: NCT03893890
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-03-26
• Study Start: 2019-03-28
• Study First Posted: 2019-03-28
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 response to treatment, approximately 3 years post treatment in EN3835-201 Study	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 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 response to treatment, approximately 3 years post treatment in EN3835-201 Study	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 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), approximately 3 years post treatment in EN3835-201 Study	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 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), approximately 3 years post treatment in EN3835-201 Study	Change from reference time point (Day 71) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe

Trial Locations

Locations (5)

Endo Clinical Trial Site #4; 🇺🇸 Clearwater, Florida, United States

Endo Clinical Trial Site #1; 🇺🇸 Coral Gables, Florida, United States

Endo Clinical Trial Site #5; 🇺🇸 Washington, Missouri, United States

Endo Clinical Trial Site #2; 🇺🇸 New York, New York, United States

Endo Clinical Trial Site #3; 🇺🇸 Charlottesville, Virginia, United States