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NCT04580303 · ClinicalTrials.gov registry record · Phase 2

CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

A Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT04580303: Completed Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

NCT04580303 is a Phase 2 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04580303, a Phase 2 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.

Primary Outcome

I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit

Interventions

  • DRUG collagenase clostridium histolyticum

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2020-10-01
Est. Completion 2021-09-24
Phase Phase 2

What the finished NCT04580303 record still lists

NCT04580303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which collagenase clostridium histolyticum is the first listed.

NCT04580303 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04580303 about?

NCT04580303 is a clinical study titled "CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques". This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison betwee...

What is the current status of trial NCT04580303?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-10-01. Estimated completion is 2021-09-24.

What interventions are being tested in trial NCT04580303?

The interventions under investigation include: collagenase clostridium histolyticum (DRUG).

Who is sponsoring clinical trial NCT04580303?

This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04580303's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04580303, the US trial registry maintained by the National Library of Medicine. NCT04580303 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.