CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
collagenase clostridium histolyticum (CCH)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03632993
NCT03632993Phase 2Completed
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A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of CCH for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP)

Endo Pharmaceuticals·interventional·Posted Aug 16, 2018·Updated Sep 7, 2023

In Brief

A Phase 2 clinical trial evaluating collagenase clostridium histolyticum (CCH) for Edematous Skin. Completed, enrolled 64 participants across 5 sites.

Detailed Summary

The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous Skin
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 16, 2018
Enrollment StartSep 18, 2018
Primary CompletionJan 24, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.9 years ago

Interventions

collagenase clostridium histolyticum (CCH)drug

Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.