Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
NCT ID: NCT03893890
Last Updated: 2019-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2019-03-28
2019-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Previously Treated with EN3835
No treatment to be administered - Observational only
Interventions
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Previously Treated with EN3835
No treatment to be administered - Observational only
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Chajko
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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EN3835-219
Identifier Type: -
Identifier Source: org_study_id
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