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Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381117
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment
Edematous Fibrosclerotic Panniculopathy Drug: Previously Treated with EN3835

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : June 22, 2020
Actual Study Completion Date : June 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
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.
Drug: Previously Treated with EN3835
No treatment to be administered - Observational only




Primary Outcome Measures :
  1. CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study [ Time Frame: Approximately 4 weeks ]
    Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)

  2. PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study [ Time Frame: Approximately 4 weeks ]
    Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  1. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
  2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

  1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
  2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
  3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
  4. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
  5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381117


Locations
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United States, Florida
Clinical Trial Site #4
Clearwater, Florida, United States, 33756
Endo Clinical Trial Site #2
Coral Gables, Florida, United States, 33146
United States, Missouri
Endo Clinical Trial Site #3
Washington, Missouri, United States, 63090
United States, New York
Endo Clinical Trial Site #1
New York, New York, United States, 10065
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Chajko Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04381117    
Other Study ID Numbers: EN3835-220
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Endo Pharmaceuticals:
EFP
Cellulite
Additional relevant MeSH terms:
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Edema