An observational study in Cellulite, Laxity; Skin and Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals. Completed at 3 sites in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Observational
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
Browse Cellulite studies →Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study.
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
Time frame: 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
Time frame: Day 540
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.
Time frame: Day 360 and Day 540
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).
Time frame: 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).
Time frame: Day 360 and Day 540
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Sep 2022, 7 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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