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Real World CCH Study in Adult Females With Cellulite

Primary Purpose

Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EN3835
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edematous Fibrosclerotic Panniculopathy (EFP)

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Endo Clinical Trial Site #2
  • Endo Clinical Trial Site #4
  • Endo Clinical Trial Site #5
  • Endo Clinical Trial Site #9
  • Endo Clinical Trial Site #1
  • Endo Clinical Trial Site #10
  • Endo Clinical Trial Site #3
  • Endo Clinical Trial Site #11
  • Endo Clinical Trial Site #8
  • Endo Clinical Trial Site #6
  • Endo Clinical Trial Site #12
  • Endo Clinical Trial Site #7

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: Posterolateral Thigh

Cohort 2: Buttocks

Arm Description

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

Outcomes

Primary Outcome Measures

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
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 Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
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".

Secondary Outcome Measures

Mean Change From Baseline in CR-PCSS for Each Buttock
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 Based on Total Score
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 Based on Total Score
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
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
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 Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
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".
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.

Full Information

First Posted
November 18, 2019
Last Updated
January 28, 2022
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04170296
Brief Title
Real World CCH Study in Adult Females With Cellulite
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Posterolateral Thigh
Arm Type
Experimental
Arm Description
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
Arm Title
Cohort 2: Buttocks
Arm Type
Experimental
Arm Description
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
Intervention Type
Drug
Intervention Name(s)
EN3835
Intervention Description
Collagenase Clostridium Histolyticum (CCH)
Primary Outcome Measure Information:
Title
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Description
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".
Time Frame
90 Days
Title
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Description
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".
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in CR-PCSS for Each Buttock
Description
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.
Time Frame
Day 22, 43, 90 and 180
Title
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Description
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
Time Frame
Day 90, Day 180
Title
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Description
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
Time Frame
Day 90, Day 180
Title
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Description
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".
Time Frame
Day 22, 43, and 180
Title
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Description
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".
Time Frame
Day 22, 43, and 180
Title
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Description
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time Frame
Day 1, 90, and 180
Title
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Description
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time Frame
Day 1, 90 and 180
Title
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Description
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time Frame
Day 1, 90 and 180
Title
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Description
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time Frame
Day 1, 90 and 180

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have both buttocks or both posterolateral thighs with: A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). 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. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study. Be judged to be in good health. Have a negative pregnancy test. Be willing and able to cooperate with the requirements of the study. Exclusion Criteria: 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). Has a history of sensitivity or allergy to collagenase or any other excipient of CCH. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance). Requires anticoagulant or antiplatelet medication during the study. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation. 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. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit. 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. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hernandez
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Endo Clinical Trial Site #2
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Endo Clinical Trial Site #4
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Endo Clinical Trial Site #5
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
Facility Name
Endo Clinical Trial Site #9
City
Westport
State/Province
Connecticut
ZIP/Postal Code
00688
Country
United States
Facility Name
Endo Clinical Trial Site #1
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Endo Clinical Trial Site #10
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Endo Clinical Trial Site #3
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Endo Clinical Trial Site #11
City
Itasca
State/Province
Illinois
ZIP/Postal Code
60143
Country
United States
Facility Name
Endo Clinical Trial Site #8
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States
Facility Name
Endo Clinical Trial Site #6
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Endo Clinical Trial Site #12
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Endo Clinical Trial Site #7
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Real World CCH Study in Adult Females With Cellulite

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