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All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment - previously treated in parent study | Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas | Day 360 |
| Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas | Day 540 |
| Measure | Description | Time Frame |
|---|---|---|
| I-GAIS ratings | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse) to determine the degree of improvement of the treated areas. | Day 360 and Day 540 |
| Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh |
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Inclusion Criteria:
Exclusion Criteria:
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The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population.
The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.
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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 #2 | Coral Gables | Florida | 33146 | United States | ||
| Endo Clinical Trial Site #3 |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
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Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse). |
| Day 360 and Day 540 |
| Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS | Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale ranging from "0" (low) to "3" (high). | Day 360 and Day 540 |
| Metairie |
| Louisiana |
| 70006 |
| United States |
| Endo Clinical Trial Site #1 | New York | New York | 10021 | United States |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |