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

NCT03893890 | Completed FDA Drug

• 1 other identifier: EN3835-219
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 5

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.

Conditions

Edematous Fibrosclerotic Panniculopathy

Keywords

Edematous Fibrosclerotic Panniculopathy; EFP; Cellulite

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Previously Treated with EN3835 BIOLOGICAL

No treatment to be administered - Observational only

No Treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• To qualify for the study a subject must:
• 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).
• 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.
• Be willing and able to comply with all protocol required visits and assessments.

You may not qualify if:

• Subjects will be ineligible for participation in this study if the subject:
• Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202.
• Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
• Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.
• Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
• Any investigational treatment for EFP/cellulite.
• Endermologie® or similar treatments.
• Massage therapy.
• Creams (eg, Celluvera™, TriLastin®).
• Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (5)

Endo Clinical Trial Site #4

Clearwater, Florida, 33756, United States

Location

Endo Clinical Trial Site #1

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #5

Washington, Missouri, 63090, United States

Location

Endo Clinical Trial Site #2

New York, New York, 10065, United States

Location

Endo Clinical Trial Site #3

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Chajko

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 28, 2019
• Study Start: March 28, 2019
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

US (5)