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Real World CCH Study in Adult Females With Cellulite

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: NCT04170296
Recruitment Status : Completed
First Posted : November 20, 2019
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 18, 2019
First Posted Date  ICMJE November 20, 2019
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE November 1, 2019
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • 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 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
  • 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 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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".
  • 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".
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • 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.
  • 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. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
  • 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. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real World CCH Study in Adult Females With Cellulite
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Edematous Fibrosclerotic Panniculopathy (EFP)
  • Cellulite
Intervention  ICMJE Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)
Study Arms  ICMJE
  • Experimental: Cohort 1: Posterolateral Thigh
    EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
    Intervention: Drug: EN3835
  • Experimental: Cohort 2: Buttocks
    EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
    Intervention: Drug: EN3835
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2020)
153
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
150
Actual Study Completion Date  ICMJE January 8, 2021
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 scarring, 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 in any manner, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04170296
Other Study ID Numbers  ICMJE EN3835-305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Hernandez Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP