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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously Treated with EN3835 | Biological | No treatment to be administered - Observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
To qualify for the study a subject must:
Exclusion Criteria:
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.
Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Chajko | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #4 | Clearwater | Florida | 33756 | United States | ||
| Endo Clinical Trial Site #1 |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Coral Gables |
| Florida |
| 33146 |
| United States |
| Endo Clinical Trial Site #5 | Washington | Missouri | 63090 | United States |
| Endo Clinical Trial Site #2 | New York | New York | 10065 | United States |
| Endo Clinical Trial Site #3 | Charlottesville | Virginia | 22911 | United States |