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CompletedNCT04170296Updated Feb 22, 2022Results posted

Real World CCH Study in Adult Females With Cellulite

A Phase 3 interventional study of EN3835 in Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 12 sites in 2 countries. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-22.

Sponsored by Endo Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Edematous Fibrosclerotic Panniculopathy (EFP)
  • Cellulite

Browse trials for

03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    Cohort 1: Posterolateral Thigh

    EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

    Drug: EN3835

  • Experimental
    Cohort 2: Buttocks

    EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

    Drug: EN3835

Interventions

  • DrugEN3835

    Collagenase Clostridium Histolyticum (CCH)

05

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 90 Days

  2. 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".

    Time frame: 90 Days

Secondary outcomes

  1. 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.

    Time frame: Day 22, 43, 90 and 180

  2. 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

    Time frame: Day 90, Day 180

  3. 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

    Time frame: Day 90, Day 180

  4. 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".

    Time frame: Day 22, 43, and 180

  5. 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".

    Time frame: Day 22, 43, and 180

  6. 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

    Time frame: Day 1, 90, and 180

  7. 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

    Time frame: Day 1, 90 and 180

  8. 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.

    Time frame: Day 1, 90 and 180

  9. 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.

    Time frame: Day 1, 90 and 180

06

Results

Posted Feb 22, 2022

Participant flow

Participant flow — Overall Study
MilestoneCohort 1: Posterolateral ThighCohort 2: Buttocks
Started8172
Completed7368
Not completed84
Withdrew: Adverse event10
Withdrew: Withdrawal by subject32
Withdrew: Lost to follow-up42

Outcome measures

PrimaryThe 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".

Time frame:
90 Days
Reported as:
Count of participants · Participants
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
ParticipantsCohort 1: Posterolateral Thigh
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh58
PrimaryThe 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".

Time frame:
90 Days
Reported as:
Count of participants · Participants
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
ParticipantsCohort 2: Buttocks
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock58
SecondaryMean 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.

Time frame:
Day 22, 43, 90 and 180
Reported as:
Mean · units on a scale
Mean Change From Baseline in CR-PCSS for Each Buttock
units on a scaleCohort 2: Buttocks (Left)Cohort 2: Buttocks (Right)
Day 22-0.3 ± 0.52-0.3 ± 0.50
Day 43-0.6 ± 0.63-0.5 ± 0.59
Day 90-0.7 ± 0.70-0.7 ± 0.53
Day 180-0.7 ± 0.63-0.6 ± 0.63
SecondaryMean 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

Time frame:
Day 90, Day 180
Reported as:
Mean · units on a scale
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
units on a scaleCohort 1: Posterolateral Thigh
Day 9010.9 ± 9.84
Day 18010.9 ± 9.76
SecondaryMean 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

Time frame:
Day 90, Day 180
Reported as:
Mean · units on a scale
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
units on a scaleCohort 2: Buttocks
Day 908.8 ± 8.38
Day 1808.8 ± 9.57
SecondaryThe 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".

Time frame:
Day 22, 43, and 180
Reported as:
Count of participants · Participants
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
ParticipantsCohort 1: Posterolateral Thigh
Day 2264
Day 4359
Day 18061
SecondaryThe 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".

Time frame:
Day 22, 43, and 180
Reported as:
Count of participants · Participants
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
ParticipantsCohort 2: Buttocks
Day 2250
Day 4362
Day 18059
SecondaryPercentage 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

Time frame:
Day 1, 90, and 180
Reported as:
Count of participants · Participants
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
ParticipantsCohort 1: Posterolateral Thigh (Anti AUX-I)Cohort 1: Posterolateral Thigh (Anti AUX-II)
Day 155
Day 906060
Day 1806868
SecondaryPercentage 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

Time frame:
Day 1, 90 and 180
Reported as:
Count of participants · Participants
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
ParticipantsCohort 2: Buttocks (Anti AUX-I)Cohort 2: Buttocks (Anti AUX-II)
Day 175
Day 906161
Day 1806665
SecondaryPresence 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.

Time frame:
Day 1, 90 and 180
Reported as:
Count of participants · Participants
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
ParticipantsCohort 1: Posterolateral Thigh (Anti AUX-I)Cohort 1: Posterolateral Thigh (Anti AUX-II)
Day 1 — Positive10
Day 1 — Negative11
Day 90 — Positive1316
Day 90 — Negative01
Day 180 — Positive812
Day 180 — Negative33
SecondaryPresence 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.

Time frame:
Day 1, 90 and 180
Reported as:
Count of participants · Participants
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
ParticipantsCohort 2: Buttocks (Anti AUX-I)Cohort 2: Buttocks (Anti AUX-II)
Day 1 — Positive22
Day 1 — Negative00
Day 90 — Positive159
Day 90 — Negative24
Day 180 — Positive159
Day 180 — Negative24

Adverse events

Collected over Time of informed consent signature until Day 180. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: Posterolateral Thigh0/81 (0%)0/81 (0%)75/81 (92.6%)
Cohort 2: Buttocks0/72 (0%)0/72 (0%)69/72 (95.8%)
Most frequent other events
Showing 10 of 40
Most frequent other events
EventCohort 1: Posterolateral ThighCohort 2: Buttocks
Injection site bruisingGeneral disorders70/8167/72
Injection site painGeneral disorders53/8157/72
Injection site discolourationGeneral disorders14/8124/72
Injection site pruritusGeneral disorders10/8114/72
Injection site swellingGeneral disorders12/8113/72
Injection site oedemaGeneral disorders8/815/72
Injection site noduleGeneral disorders7/815/72
Injection site massGeneral disorders4/815/72
Post-inflammatory pigmentation changeSkin and subcutaneous tissue disorders5/812/72
Injection site haemorrhageGeneral disorders3/812/72

Baseline characteristics

Safety Population includes all participants who have at least 1 injection of study medication.

Age, Continuous
Age, Continuous(years)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Mean43.2 ± 9.4042.7 ± 9.3543.0 ± 9.35
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Female8172153
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Hispanic or Latino101828
Not Hispanic or Latino7154125
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
American Indian or Alaska Native000
Asian224
Native Hawaiian or Other Pacific Islander101
Black or African American224
White7465139
More than one race011
Unknown or Not Reported224
Weight
Weight(kg)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Mean65.082 ± 8.334165.042 ± 8.940365.063 ± 8.5961
Height
Height(cm)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Mean164.548 ± 6.2671165.192 ± 6.6315164.851 ± 6.4279
BMI
BMI(kg/m^2)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
Mean24.03 ± 2.64023.89 ± 2.75923.96 ± 2.689
Skin Category (Fitzpatrick Scale)
Skin Category (Fitzpatrick Scale)(Participants)Cohort 1: Posterolateral ThighCohort 2: ButtocksTotal
I (Pale White)213
II (Fair)332457
III (Darker White)242852
IV (Light Brown)181432
V (Brown)448
VI (Dark Brown or Black)011
07

Study locations

12 sites
  • Endo Clinical Trial Site #2
    Encino, California 91436, United States
  • Endo Clinical Trial Site #4
    San Diego, California 92121, United States
  • Endo Clinical Trial Site #5
    Solana Beach, California 92075, United States
  • Endo Clinical Trial Site #9
    Westport, Connecticut 00688, United States
  • Endo Clinical Trial Site #1
    Coral Gables, Florida 33146, United States
  • Endo Clinical Trial Site #10
    Alpharetta, Georgia 30005, United States
  • Endo Clinical Trial Site #3
    Chicago, Illinois 60611, United States
  • Endo Clinical Trial Site #11
    Itasca, Illinois 60143, United States
  • Endo Clinical Trial Site #8
    New Orleans, Louisiana 70130, United States
  • Endo Clinical Trial Site #6
    New York, New York 10021, United States
  • Endo Clinical Trial Site #12
    Nashville, Tennessee 37215, United States
  • Endo Clinical Trial Site #7
    San Juan, 00917, Puerto Rico
08

References and documents

Study documents

  • Study protocol · Jun 1, 2020
  • Statistical analysis plan · Jul 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT04170296
Lead sponsor
Endo Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 20, 2019
Start date
Nov 1, 2019
Primary completion
Oct 6, 2020
Completion
Jan 8, 2021
Results posted
Feb 22, 2022
Last update
Feb 22, 2022

Study contacts

David Hernandez
study director · Endo Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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