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Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209530
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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Brief Summary:
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).

Condition or disease Intervention/treatment Phase
Cellulite Edematous Fibrosclerotic Panniculopathy (EFP) Drug: EN3835 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Buttock
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
 Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)
Experimental: Posterolateral Thigh
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
 Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)


Outcome Measures
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Primary Outcome Measures :
  1. The change from baseline (screening) in PR-PCSS [ Time Frame: Day 71 ]
    Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective


Secondary Outcome Measures :
  1. The change from baseline (screening) in CR-PCSS [ Time Frame: Day 22, Day 43 and Day 71 ]
    Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a clinician's perspective

  2. The change from baseline (screening) in Hexsel Cellulite Severity Scale (CSS) [ Time Frame: Day 22, Day 43 and Day 71 ]
    Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)

  3. MRI before and after CCH treatment [ Time Frame: Day 71 ]
    Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment

  4. Histopathology before and after CCH treatment [ Time Frame: Day 71 ]
    Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have both buttocks or both posterolateral thighs with:

    1. A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
    2. A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident Depressions" score of >0, and Subsection B "Depth of Depressions" score of 2 )medium depth depression) or 3 (deep depressions)..
  2. Have a minimum of 2 well defined and isolated cellulite dimples.
  3. Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).
  4. Be judged to be in good health.
  5. Have a negative pregnancy test.
  6. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

  1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
  3. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
  4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
  5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
  6. Requires anticoagulant or antiplatelet medication during the study.
  7. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
  8. Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit).
  9. Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening.
  10. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment.
  11. Has a history of keloids, hypertrophied scars, and/or other complications following biopsy.
  12. Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation.
  13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
  14. Has previously received treatment with CCH in this clinical study.
  15. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
  16. Is pregnant and/or is providing breast milk or plans to become pregnant and/or to provide breast milk during the course of the study.
  17. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Contacts and Locations
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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): NCT04209530


Contacts
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Contact: Jason Herter 800-462-3636 ClinicalTrials@endo.com
Contact: Catherine Kacprzycki 800-462-3636 ClinicalTrials@endo.com

Locations
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United States, Florida
Endo Clinical Trial Site #1 Recruiting
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Ashley Dayoub Endo Pharmaceuticals
More Information
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04209530    
Other Study ID Numbers: EN3835-212
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
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
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Signs and Symptoms