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This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment | Subjects who participated in and completed study EN3835-201 and had composite improvement of at least 2-levels on both the Clinician Reported-Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported-Photonumeric Cellulite Severity Scale (PR-PCSS) in EN3835-201 study will be eligible for this study. The study will consist of a single day evaluation approximately 4 years after the first dose of the study drug was received in the EN3835-201 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously Treated with EN3835 | Drug | No treatment to be administered - Observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) | Approximately 4 weeks |
| PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) | Approximately 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The Durability Population, defined as all subjects in the Safety Population who have both CR-PCSS and PR-PCSS assessments at Visit 1 (Month 48).
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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 |
|---|---|---|---|---|---|---|
| Clinical Trial Site #4 | Clearwater | Florida | 33756 | United States | ||
| Endo Clinical Trial Site #2 |
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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 #3 | Washington | Missouri | 63090 | United States |
| Endo Clinical Trial Site #1 | New York | New York | 10065 | United States |