Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Real World, Multicenter, Open-Label Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Cellulite in Adult Females

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: NCT04170296
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).

Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.


Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite Drug: EN3835 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Cohort 1: Posterolateral Thigh Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)

Experimental: Cohort 2: Buttocks Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)




Primary Outcome Measures :
  1. The proportion of subjects with improved (+1 or better) score on I-GAIS for either posterolateral thigh [ Time Frame: Approximately 90 Days ]
    Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Worse," "No Change," "Improved," "Much Improved," and "Very Much Improved".

  2. The proportion of subjects with improved (+1 or better) score on I-GAIS for either buttock [ Time Frame: Approximately 90 Days ]
    Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Worse," "No Change," "Improved," "Much Improved," and "Very Much Improved".


Secondary Outcome Measures :
  1. Mean change from baseline in CR-PCSS for each buttock [ Time Frame: Approximately 7 Months ]
    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. Mean change from baseline in Body Q Appraisal of Cellulite for posterolateral thigh [ Time Frame: Approximately 7 Months ]
    The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring.

  3. Mean change from baseline in Body Q Appraisal of Cellulite for buttock [ Time Frame: Approximately 7 Months ]
    The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 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 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
    2. A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
  2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
  3. Be judged to be in good health.
  4. Have a negative pregnancy test.
  5. 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. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
  7. Requires anticoagulant or antiplatelet medication during the study.
  8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
  9. Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
  10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
  11. 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.
  12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject 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): NCT04170296


Contacts
Layout table for location contacts
Contact: Lindsay Laudal 800-462-3636 ClinicalTrials@Endo.com
Contact: Davina Cupo 800-462-3636 ClinicalTrials@Endo.com

Locations
Layout table for location information
United States, California
Endo Clinical Trial Site #2 Recruiting
Encino, California, United States, 91436
Endo Clinical Trial Site #4 Recruiting
San Diego, California, United States, 92121
United States, Florida
Endo Clinical Trial Site #1 Recruiting
Coral Gables, Florida, United States, 33146
United States, Illinois
Endo Clinical Trial Site #3 Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Jill Edgecombe Endo Pharmaceuticals

Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04170296     History of Changes
Other Study ID Numbers: EN3835-305
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cellulite
Skin Manifestations
Signs and Symptoms