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

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ClinicalTrials.gov Identifier: NCT03893890
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Edematous Fibrosclerotic Panniculopathy Biological: Previously Treated with EN3835

Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy
Actual Study Start Date : March 28, 2019
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 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

  2. 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) [ Time Frame: 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

  3. 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) [ Time Frame: 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

  4. 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) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893890


Locations
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United States, Florida
Endo Clinical Trial Site #4
Clearwater, Florida, United States, 33756
Endo Clinical Trial Site #1
Coral Gables, Florida, United States, 33146
United States, Missouri
Endo Clinical Trial Site #5
Washington, Missouri, United States, 63090
United States, New York
Endo Clinical Trial Site #2
New York, New York, United States, 10065
United States, Virginia
Endo Clinical Trial Site #3
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Chajko Endo Pharmaceuticals
More Information
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03893890    
Other Study ID Numbers: EN3835-219
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Endo Pharmaceuticals:
Edematous Fibrosclerotic Panniculopathy
EFP
Cellulite
Additional relevant MeSH terms:
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Edema