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
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Condition or disease | Intervention/treatment |
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Edematous Fibrosclerotic Panniculopathy | Biological: Previously Treated with EN3835 |
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 |
Group/Cohort | Intervention/treatment |
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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.
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Biological: Previously Treated with EN3835
No treatment to be administered - Observational only |
- 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
- 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
- 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
- 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

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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 |
Inclusion Criteria:
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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.
Exclusion Criteria:
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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.
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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.

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
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 |
Study Director: | Karen Chajko | Endo Pharmaceuticals |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Edematous Fibrosclerotic Panniculopathy EFP Cellulite |
Edema |